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1. Neutralizing antibody correlate of protection against severe-critical COVID-19 in the ENSEMBLE single-dose Ad26.COV2.S vaccine efficacy trial

Author

Carpp, Lindsay N., Hyrien, Ollivier, Fong, Youyi, Benkeser, David, Roels, Sanne, Stieh, Daniel J., Van Dromme, Ilse, Van Roey, Griet A., Kenny, Avi, Huang, Ying, Carone, Marco, McDermott, Adrian B., Houchens, Christopher R., Martins, Karen, Jayashankar, Lakshmi, Castellino, Flora, Amoa-Awua, Obrimpong, Basappa, Manjula, Flach, Britta, Lin, Bob C., Moore, Christopher, Naisan, Mursal, Naqvi, Muhammed, Narpala, Sandeep, O’Connell, Sarah, Mueller, Allen, Serebryannyy, Leo, Castro, Mike, Wang, Jennifer, Petropoulos, Christos J., Luedtke, Alex, Lu, Yiwen, Yu, Chenchen, Juraska, Michal, Hejazi, Nima S., Wolfe, Daniel N., Sadoff, Jerald, Gray, Glenda E., Grinsztejn, Beatriz, Goepfert, Paul A., Bekker, Linda-Gail, Gaur, Aditya H., Veloso, Valdilea G., Randhawa, April K., Andrasik, Michele P., Hendriks, Jenny, Truyers, Carla, Vandebosch, An, Struyf, Frank, Schuitemaker, Hanneke, Douoguih, Macaya, Kublin, James G., Corey, Lawrence, Neuzil, Kathleen M., Follmann, Dean, Koup, Richard A., Donis, Ruben O., and Gilbert, Peter B.

Published
2024
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2. Omicron COVID-19 immune correlates analysis of a third dose of mRNA-1273 in the COVE trial

Author

Zhang, Bo, Fong, Youyi, Fintzi, Jonathan, Chu, Eric, Janes, Holly E., Kenny, Avi, Carone, Marco, Benkeser, David, van der Laan, Lars W. P., Deng, Weiping, Zhou, Honghong, Wang, Xiaowei, Lu, Yiwen, Yu, Chenchen, Borate, Bhavesh, Chen, Haiyan, Reeder, Isabel, Carpp, Lindsay N., Houchens, Christopher R., Martins, Karen, Jayashankar, Lakshmi, Huynh, Chuong, Fichtenbaum, Carl J., Kalams, Spyros, Gay, Cynthia L., Andrasik, Michele P., Kublin, James G., Corey, Lawrence, Neuzil, Kathleen M., Priddy, Frances, Das, Rituparna, Girard, Bethany, El Sahly, Hana M., Baden, Lindsey R., Jones, Thomas, Donis, Ruben O., Koup, Richard A., Gilbert, Peter B., and Follmann, Dean

Published
2024
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5. Polytopic fractional delivery of an HIV vaccine alters cellular responses and results in increased epitope breadth in a phase 1 randomized trial

Author

Miner, Maurine D, deCamp, Allan, Grunenberg, Nicole, De Rosa, Stephen C, Fiore-Gartland, Andrew, Bar, Katherine, Spearman, Paul, Allen, Mary, Yu, Pei-Chun, Manso, Bryce, Frahm, Nicole, Kalams, Spyros, Baden, Lindsey, Keefer, Michael C, Scott, Hyman M, Novak, Richard, Van Tieu, Hong, Tomaras, Georgia D, Kublin, James G, McElrath, M Juliana, Corey, Lawrence, Frank, Ian, Team, HVTN 085 Study, Kalichman, Artur, Edlefsen, Paul, Enama, Mary, Hural, John, Holt, Renee, Dunbar, Debora, Crawford, Dave, Maki, Ian, Johannessen, Jan, Estep, Scharla, Grigoriev, Yevgeny, Madenwald, Tamra, Hansen, Marianne, Holman, Drienna, Fair, Ramey, Meyer, Genevieve, and Luke-Kilolam, Anya

Subjects
Medical Microbiology, Biomedical and Clinical Sciences, Immunology, Vaccine Related, Biotechnology, Infectious Diseases, Sexually Transmitted Infections, Immunization, Clinical Trials and Supportive Activities, Prevention, Clinical Research, HIV/AIDS, Vaccine Related (AIDS), 3.4 Vaccines, Infection, Good Health and Well Being, Humans, AIDS Vaccines, Epitopes, HIV Infections, CD4-Positive T-Lymphocytes, Vaccination, Immunoglobulin G, HIV, Fractionated delivery, Polytopic vaccination, Ad5, Epitope breadth, HVTN 085 Study Team, Clinical Sciences, Public Health and Health Services, Clinical sciences, Epidemiology
Abstract

BackgroundElicitation of broad immune responses is understood to be required for an efficacious preventative HIV vaccine. This Phase 1 randomized controlled trial evaluated whether administration of vaccine antigens separated at multiple injection sites vs combined, fractional delivery at multiple sites affected T-cell breadth compared to standard, single site vaccination.MethodsWe randomized 90 participants to receive recombinant adenovirus 5 (rAd5) vector with HIV inserts gag, pol and env via three different strategies. The Standard group received vaccine at a single anatomic site (n = 30) compared to two polytopic (multisite) vaccination groups: Separated (n = 30), where antigens were separately administered to four anatomical sites, and Fractioned (n = 30), where fractions of each vaccine component were combined and administered at four sites. All groups received the same total dose of vaccine.FindingsCD8 T-cell response rates and magnitudes were significantly higher in the Fractioned group than Standard for several antigen pools tested. CD4 T-cell response magnitudes to Pol were higher in the Separated than Standard group. T-cell epitope mapping demonstrated greatest breadth in the Fractioned group (median 8.0 vs 2.5 for Standard, Wilcoxon p = 0.03; not significant after multiplicity adjustment for co-primary endpoints). IgG binding antibody response rates to Env were higher in the Standard and Fractioned groups vs Separated group.InterpretationThis study shows that the number of anatomic sites for which a vaccine is delivered and distribution of its antigenic components influences immune responses in humans.FundingNational Institute of Allergy and Infectious Diseases, NIH.

Published
2024

6. Risk of COVID-19 after natural infection or vaccination

Author

Rick, Anne-Marie, Laurens, Matthew B, Huang, Ying, Yu, Chenchen, Martin, Thomas CS, Rodriguez, Carina A, Rostad, Christina A, Maboa, Rebone M, Baden, Lindsey R, Sahly, Hana M El, Grinsztejn, Beatriz, Gray, Glenda E, Gay, Cynthia L, Gilbert, Peter B, Janes, Holly E, Kublin, James G, Huang, Yunda, Leav, Brett, Hirsch, Ian, Struyf, Frank, Dunkle, Lisa M, Neuzil, Kathleen M, Corey, Lawrence, Goepfert, Paul A, Walsh, Stephen R, Follmann, Dean, Kotloff, Karen L, Adams, Atoya, Miller, Eric, Rankin, Bruce G, Shinn, Steven, Nash, Marshall, Green, Sinikka L, Jacobsen, Colleen, Krishnankutty, Jayasree, Phungwayo, Sikhongi, Glover, Richard M, Slechta, Stacy, Holdeman, Troy, Hartvickson, Robyn, Grant, Amber, Poling, Terry L, Klein, Terry D, Klein, Thomas C, Klein, Tracy R, Smith, William B, Gibson, Richard L, Winbigler, Jennifer, Parker, Elizabeth, Wijewardane, Priyantha N, Bravo, Eric, Thessing, Jeffrey, Maxwell, Michelle, Horn, Amanda, Healy, Catherine Mary, Akamine, Christine, Chu, Laurence, Chouteau, R Michelle, Cotugno, Michael J, Bauer, George H, Hachigian, Greg, Oshita, Masaru, Cancilla, Michael, Kiersey, Kristen, Seger, William, Antwi, Mohammed, Green, Allison, Kim, Anthony, Desjardins, Michael, Johnson, Jennifer A, Sherman, Amy, Borger, Judith, Saleem, Nafisa, Solis, Joel, Medina, Martha Carmen, Keating, Westly, Garcia, Edgar, Bueno, Cynthia, Segall, Nathan, Denham, Douglas S, Weiss, Thomas, Avworo, Ayoade, Hedges, Parke, Strout, Cynthia Becher, Santiago, Rica, Davis, Yvonne, Howenstine, Patty, Bondell, Alison, Marks, Kristin, Wang, Tina, Wilkin, Timothy, Vogler, Mary, Johnston, Carrie, Andrasik, Michele P, Andriesen, Jessica G, Broder, Gail, Eaton, Niles, Gelderblom, Huub G, and McClennen, Rachael

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Research, Immunization, Coronaviruses, Biotechnology, Clinical Trials and Supportive Activities, Infectious Diseases, Emerging Infectious Diseases, Vaccine Related, Prevention, 6.1 Pharmaceuticals, 3.4 Vaccines, Infection, Good Health and Well Being, Humans, COVID-19, COVID-19 Vaccines, Pandemics, SARS-CoV-2, United States, Vaccination, Natural infection, Hybrid immunity, NIAID-funded COVID-19 Prevention Network, natural infection, hybrid immunity, vaccination, Public Health and Health Services, Clinical sciences, Epidemiology
Abstract

BackgroundWhile vaccines have established utility against COVID-19, phase 3 efficacy studies have generally not comprehensively evaluated protection provided by previous infection or hybrid immunity (previous infection plus vaccination). Individual patient data from US government-supported harmonized vaccine trials provide an unprecedented sample population to address this issue. We characterized the protective efficacy of previous SARS-CoV-2 infection and hybrid immunity against COVID-19 early in the pandemic over three-to six-month follow-up and compared with vaccine-associated protection.MethodsIn this post-hoc cross-protocol analysis of the Moderna, AstraZeneca, Janssen, and Novavax COVID-19 vaccine clinical trials, we allocated participants into four groups based on previous-infection status at enrolment and treatment: no previous infection/placebo; previous infection/placebo; no previous infection/vaccine; and previous infection/vaccine. The main outcome was RT-PCR-confirmed COVID-19 >7-15 days (per original protocols) after final study injection. We calculated crude and adjusted efficacy measures.FindingsPrevious infection/placebo participants had a 92% decreased risk of future COVID-19 compared to no previous infection/placebo participants (overall hazard ratio [HR] ratio: 0.08; 95% CI: 0.05-0.13). Among single-dose Janssen participants, hybrid immunity conferred greater protection than vaccine alone (HR: 0.03; 95% CI: 0.01-0.10). Too few infections were observed to draw statistical inferences comparing hybrid immunity to vaccine alone for other trials. Vaccination, previous infection, and hybrid immunity all provided near-complete protection against severe disease.InterpretationPrevious infection, any hybrid immunity, and two-dose vaccination all provided substantial protection against symptomatic and severe COVID-19 through the early Delta period. Thus, as a surrogate for natural infection, vaccination remains the safest approach to protection.FundingNational Institutes of Health.

Published
2023

7. Modifiers of COVID-19 vaccine efficacy: Results from four COVID-19 prevention network efficacy trials.

Author

Turley, Christine B, Tables, LaKesha, Fuller, Trevon, Sanders, Lisa J, Scott, Hyman, Moodley, Amaran, Woodward Davis, Amanda, Leav, Brett, Miller, Jacqueline, Schoemaker, Kathryn, Vandebosch, An, Sadoff, Jerald, Woo, Wayne, Cho, Iksung, Dunkle, Lisa M, Li, Sijia, van der Laan, Lars, Gilbert, Peter B, Follmann, Dean, Jaynes, Holly, Kublin, James G, Baden, Lindsey R, Goepfert, Paul, Kotloff, Karen, Gay, Cynthia L, Falsey, Ann R, El Sahly, Hana M, Sobieszczyk, Magdalena E, Huang, Yunda, Neuzil, Kathleen M, Corey, Lawrence, Grinsztejn, Beatriz, Gray, Glenda, Rouphael, Nadine, Luedtke, Alex, and COVID-19 Prevention Network CoVPN

Subjects
COVID-19 Prevention Network CoVPN, Humans, Adult, COVID-19, COVID-19 Vaccines, 2019-nCoV Vaccine mRNA-1273, Ad26COVS1, ChAdOx1 nCoV-19, Comorbidity, Effect modifier, Environmental exposure, Epidemiologic, Occupational exposure, SARS-CoV-2, Vaccine efficacy, Clinical Research, Prevention, Clinical Trials and Supportive Activities, Infectious Diseases, Vaccine Related, Immunization, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Prevention of disease and conditions, and promotion of well-being, 3.4 Vaccines, Infection, Good Health and Well Being, Biological Sciences, Agricultural and Veterinary Sciences, Medical and Health Sciences, Virology
Abstract

Questions remain regarding the effect of baseline host and exposure factors on vaccine efficacy (VE) across pathogens and vaccine platforms. We report placebo-controlled data from four Phase 3 COVID-19 trials during the early period of the pandemic. This was a cross-protocol analysis of four randomized, placebo-controlled efficacy trials (Moderna/mRNA1273, AstraZeneca/AZD1222, Janssen/Ad26.COV2.S, and Novavax/NVX-CoV2373) using a harmonized design. Trials were conducted in the United States and international sites in adults ≥ 18 years of age. VE was assessed for symptomatic and severe COVID-19. We analyzed 114,480 participants from both placebo and vaccine arms, enrolled July 2020 to February 2021, with follow up through July 2021. VE against symptomatic COVID-19 showed little heterogeneity across baseline socio-demographic, clinical or exposure characteristics, in either univariate or multivariate analysis, regardless of vaccine platform. Similarly, VE against severe COVID-19 in the single trial (Janssen) with sufficient endpoints for analysis showed little evidence of heterogeneity. COVID-19 VE is not influenced by baseline host or exposure characteristics across efficacy trials of different vaccine platforms and countries when well matched to circulating virus strains. This supports use of these vaccines, regardless of platform type, as effective tools in the near term for reducing symptomatic and severe COVID-19, particularly for older individuals and those with common co-morbidities during major variant shifts. Clinical trial registration numbers: NCT04470427, NCT04516746, NCT04505722, and NCT04611802.

Published
2023

8. Stochastic Interventional Vaccine Efficacy and Principal Surrogate Analyses of Antibody Markers as Correlates of Protection against Symptomatic COVID-19 in the COVE mRNA-1273 Trial

Author

Huang, Ying, Hejazi, Nima S, Blette, Bryan, Carpp, Lindsay N, Benkeser, David, Montefiori, David C, McDermott, Adrian B, Fong, Youyi, Janes, Holly E, Deng, Weiping, Zhou, Honghong, Houchens, Christopher R, Martins, Karen, Jayashankar, Lakshmi, Flach, Britta, Lin, Bob C, O’Connell, Sarah, McDanal, Charlene, Eaton, Amanda, Sarzotti-Kelsoe, Marcella, Lu, Yiwen, Yu, Chenchen, Kenny, Avi, Carone, Marco, Huynh, Chuong, Miller, Jacqueline, Sahly, Hana M El, Baden, Lindsey R, Jackson, Lisa A, Campbell, Thomas B, Clark, Jesse, Andrasik, Michele P, Kublin, James G, Corey, Lawrence, Neuzil, Kathleen M, Pajon, Rolando, Follmann, Dean, Donis, Ruben O, Koup, Richard A, Gilbert, Peter B, Assays, on behalf of the Immune, Moderna, Inc, Efficacy, Coronavirus Vaccine Prevention Network Coronavirus, and Teams, Government CoVPN Biostatistics

Subjects
Microbiology, Biological Sciences, Infectious Diseases, Biotechnology, Vaccine Related, Emerging Infectious Diseases, Immunization, Coronaviruses, Good Health and Well Being, Humans, 2019-nCoV Vaccine mRNA-1273, Antibodies, Neutralizing, Antibodies, Viral, COVID-19, Immunoglobulin G, Vaccine Efficacy, binding antibody assay, immune correlates of protection, modified treatment policy, neutralizing antibody assay, principal stratification, principal surrogate, SARS-CoV-2, stochastic intervention, stochastic interventional vaccine efficacy
Abstract

The COVE trial randomized participants to receive two doses of mRNA-1273 vaccine or placebo on Days 1 and 29 (D1, D29). Anti-SARS-CoV-2 Spike IgG binding antibodies (bAbs), anti-receptor binding domain IgG bAbs, 50% inhibitory dilution neutralizing antibody (nAb) titers, and 80% inhibitory dilution nAb titers were measured at D29 and D57. We assessed these markers as correlates of protection (CoPs) against COVID-19 using stochastic interventional vaccine efficacy (SVE) analysis and principal surrogate (PS) analysis, frameworks not used in our previous COVE immune correlates analyses. By SVE analysis, hypothetical shifts of the D57 Spike IgG distribution from a geometric mean concentration (GMC) of 2737 binding antibody units (BAU)/mL (estimated vaccine efficacy (VE): 92.9% (95% CI: 91.7%, 93.9%)) to 274 BAU/mL or to 27,368 BAU/mL resulted in an overall estimated VE of 84.2% (79.0%, 88.1%) and 97.6% (97.4%, 97.7%), respectively. By binary marker PS analysis of Low and High subgroups (cut-point: 2094 BAU/mL), the ignorance interval (IGI) and estimated uncertainty interval (EUI) for VE were [85%, 90%] and (78%, 93%) for Low compared to [95%, 96%] and (92%, 97%) for High. By continuous marker PS analysis, the IGI and 95% EUI for VE at the 2.5th percentile (519.4 BAU/mL) vs. at the 97.5th percentile (9262.9 BAU/mL) of D57 Spike IgG concentration were [92.6%, 93.4%] and (89.2%, 95.7%) vs. [94.3%, 94.6%] and (89.7%, 97.0%). Results were similar for other D29 and D57 markers. Thus, the SVE and PS analyses additionally support all four markers at both time points as CoPs.

Published
2023

9. Mosaic HIV-1 vaccine regimen in southern African women (Imbokodo/HVTN 705/HPX2008): a randomised, double-blind, placebo-controlled, phase 2b trial

Author

Allagappen, Jon, Andriesen, Jessica, Ayres, Alison, Bekker, Linda-Gail, Borremans, Caroline, Brumskine, William, Chilengi, Roma, Dubula, Thozama, Garrett, Nigel, Gelderblom, Huub, Gill, Katherine, Hoosain, Zaheer, Hosseinipour, Mina, Hutter, Julia, Inambao, Mubiana, Innes, Craig, Kilembe, William, Kotze, Philippus, Kotze, Sheena, Laher, Fatima, Laszlo, Imre, Lazarus, Erica, Malahleha, Mookho, Mathebula, Matsontso, Matoga, Mitch, McClennen, Rachael, Mda, Pamela, Meerts, Peter, Naicker, Vimla, Naidoo, Logashvari, Philip, Tricia, Pitsi, Annah, Scheppler, Lorenz, Sopher, Carrie, Takuva, Simbarashe G., Viegas, Edna, Weijtens, Mo, Yuan, Olive, Gray, Glenda E, Mngadi, Kathryn, Lavreys, Ludo, Nijs, Steven, Gilbert, Peter B, Hural, John, Hyrien, Ollivier, Juraska, Michal, Luedtke, Alex, Mann, Philipp, McElrath, M Juliana, Odhiambo, Jackline A, Stieh, Daniel J, van Duijn, Janine, Takalani, Azwidihwi N, Willems, Wouter, Tapley, Asa, Tomaras, Georgia D, Van Hoof, Johan, Schuitemaker, Hanneke, Swann, Edith, Barouch, Dan H, Kublin, James G, Corey, Lawrence, Pau, Maria G, Buchbinder, Susan, and Tomaka, Frank

Published
2024
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10. Immune correlates analysis of the Imbokodo (HVTN 705/HPX2008) efficacy trial of a mosaic HIV-1 vaccine regimen evaluated in Southern African people assigned female sex at birth: a two-phase case-control study

Author

Allagappen, Jon, Andriesen, Jessica, Ayres, Alison, Baral, Saman, Bekker, Linda-Gail, Besethi, Asiphe, Borremans, Caroline, Braams, Esmee, Brackett, Caroline, Brumskine, William, Chilengi, Roma, Choi, Rachel, Dubula, Thozama, Dumas, Jaiden Seongmi, Dunn, Brooke, Etikala, Radhika, Euler, Zelda, Everett, Sarah, Garrett, Nigel, Gelderblom, Huub, Gill, Katherine, Gillespie, Kevin, Goedhart, Dimitri, Goosmann, Erik, Grant, Shannon, Hands, Ellie, Haynes, Barton, Herringer, Bronwill, Hoosain, Zaheer, Hosseinipour, Mina, Hunidzarira, Portia, Hutter, Julia, Inambao, Mubiana, Innes, Craig, Keyes, Taylor, Kilembe, William, Kotze, Philippus, Kotze, Sheena, Laher, Fatima, Laszlo, Imre, Lazarus, Erica, Liao, Hua-Xin, Lin, Yong, Lu, Helen, Lucas, Judith, Malahleha, Mookho, McNair, Tara, Meerts, Peter, Mgaga, Zinhle, Montlha, Mahlodi, Mosito, Boitumelo, Moultrie, Andrew, Mudrak, Sarah, Oriol-Mathieu, Valérie, Sarzotti-Kelsoe, Marcella, Mathebula, Matson Tso, Matoga, Mitch, McClennen, Rachael, Mda, Pamela, Naicker, Vimla, Naidoo, Logashvari, Okkers, Cindy-Ann, Omarjee, Saleha, Pasmans, Hella, Philip, Tricia, Pinter, Abraham, Pitsi, Annah, Ramos, Ornelia, Randhawa, April, Roels, Sanne, Rohith, Shamiska, Rutten, Lucy, Sadoff, Jerald, Salinas, Gabriela, Salzgeber, Yvonne, Scheppler, Lorenz, Schwedhelm, Katharine, Schuller, Nicolette, Sharak, Angelina, Stanfield-Oakley, Sherry, Sopher, Carrie, Tafatatha, Terence, Takuva, Simbarashe G., Tang, Chan, Vandebosch, An, Viegas, Edna, Voillet, Valentin, Wegmann, Frank, Weijtens, Mo, Wilcox, Stephany, Williams, Anthony, Yu, Chenchen, Yu, Pei-Chun, Yuan, Olive, Zhang, Xuehan, Kenny, Avi, van Duijn, Janine, Dintwe, One, Heptinstall, Jack, Burnham, Randy, Sawant, Sheetal, Zhang, Lu, Mielke, Dieter, Khuzwayo, Sharon, Omar, Faatima Laher, Goodman, Derrick, Fong, Youyi, Benkeser, David, Zou, Rodger, Hural, John, Hyrien, Ollivier, Juraska, Michal, Luedtke, Alex, van der Laan, Lars, Giorgi, Elena E., Magaret, Craig, Carpp, Lindsay N., Pattacini, Laura, van de Kerkhof, Tom, Korber, Bette, Willems, Wouter, Fisher, Leigh H., Schuitemaker, Hanneke, Swann, Edith, Kublin, James G., Pau, Maria G., Buchbinder, Susan, Tomaka, Frank, Nijs, Steven, Lavreys, Ludo, Gelderblom, Huub C., Corey, Lawrence, Mngadi, Kathryn, Gray, Glenda E., Borducchi, Erica, Hendriks, Jenny, Seaton, Kelly E., Zolla-Pazner, Susan, Barouch, Dan H., Ferrari, Guido, De Rosa, Stephen C., McElrath, M Juliana, Andersen-Nissen, Erica, Stieh, Daniel J., Tomaras, Georgia D., and Gilbert, Peter B.

Published
2024
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11. Safety and immunogenicity of a polyvalent DNA–protein HIV vaccine with matched Env immunogens delivered as a prime–boost regimen or coadministered in HIV-uninfected adults in the USA (HVTN 124): a phase 1, placebo-controlled, double-blind randomised controlled trial

Author

Frank, Ian, Li, Shuying S, Grunenberg, Nicole, Overton, Edgar T, Robinson, Samuel T, Zheng, Hua, Seaton, Kelly E, Heptinstall, Jack R, Allen, Mary A, Mayer, Kenneth H, Culver, Daniel A, Keefer, Michael C, Edupuganti, Sri, Pensiero, Michael N, Mehra, Vijay L, De Rosa, Stephen C, Morris, Daryl E, Wang, Shixia, Seaman, Michael S, Montefiori, David C, Ferrari, Guido, Tomaras, Georgia D, Kublin, James G, Corey, Lawrence, and Lu, Shan

Published
2024
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12. Publisher Correction: Immune correlates analysis of the PREVENT-19 COVID-19 vaccine efficacy clinical trial

Author

Fong, Youyi, Huang, Yunda, Benkeser, David, Carpp, Lindsay N., Áñez, Germán, Woo, Wayne, McGarry, Alice, Dunkle, Lisa M., Cho, Iksung, Houchens, Christopher R., Martins, Karen, Jayashankar, Lakshmi, Castellino, Flora, Petropoulos, Christos J., Leith, Andrew, Haugaard, Deanne, Webb, Bill, Lu, Yiwen, Yu, Chenchen, Borate, Bhavesh, van der Laan, Lars W. P., Hejazi, Nima S., Randhawa, April K., Andrasik, Michele P., Kublin, James G., Hutter, Julia, Keshtkar-Jahromi, Maryam, Beresnev, Tatiana H., Corey, Lawrence, Neuzil, Kathleen M., Follmann, Dean, Ake, Julie A., Gay, Cynthia L., Kotloff, Karen L., Koup, Richard A., Donis, Ruben O., and Gilbert, Peter B.

Published
2023
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13. Immune correlates analysis of the PREVENT-19 COVID-19 vaccine efficacy clinical trial

Author

Fong, Youyi, Huang, Yunda, Benkeser, David, Carpp, Lindsay N., Áñez, Germán, Woo, Wayne, McGarry, Alice, Dunkle, Lisa M., Cho, Iksung, Houchens, Christopher R., Martins, Karen, Jayashankar, Lakshmi, Castellino, Flora, Petropoulos, Christos J., Leith, Andrew, Haugaard, Deanne, Webb, Bill, Lu, Yiwen, Yu, Chenchen, Borate, Bhavesh, van der Laan, Lars W. P., Hejazi, Nima S., Randhawa, April K., Andrasik, Michele P., Kublin, James G., Hutter, Julia, Keshtkar-Jahromi, Maryam, Beresnev, Tatiana H., Corey, Lawrence, Neuzil, Kathleen M., Follmann, Dean, Ake, Julie A., Gay, Cynthia L., Kotloff, Karen L., Koup, Richard A., Donis, Ruben O., and Gilbert, Peter B.

Published
2023
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14. Immune correlates analysis of a phase 3 trial of the AZD1222 (ChAdOx1 nCoV-19) vaccine

Author

Benkeser, David, Fong, Youyi, Janes, Holly E., Kelly, Elizabeth J., Hirsch, Ian, Sproule, Stephanie, Stanley, Ann Marie, Maaske, Jill, Villafana, Tonya, Houchens, Christopher R., Martins, Karen, Jayashankar, Lakshmi, Castellino, Flora, Ayala, Victor, Petropoulos, Christos J., Leith, Andrew, Haugaard, Deanne, Webb, Bill, Lu, Yiwen, Yu, Chenchen, Borate, Bhavesh, van der Laan, Lars W. P., Hejazi, Nima S., Carpp, Lindsay N., Randhawa, April K., Andrasik, Michele P., Kublin, James G., Isaacs, Margaret Brewinski, Makhene, Mamodikoe, Tong, Tina, Robb, Merlin L., Corey, Lawrence, Neuzil, Kathleen M., Follmann, Dean, Hoffman, Corey, Falsey, Ann R., Sobieszczyk, Magdalena, Koup, Richard A., Donis, Ruben O., and Gilbert, Peter B.

Published
2023
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15. Polytopic fractional delivery of an HIV vaccine alters cellular responses and results in increased epitope breadth in a phase 1 randomized trial

Author

Kalichman, Artur, Edlefsen, Paul, Enama, Mary, Hural, John, Holt, Renee, Dunbar, Debora, Crawford, Dave, Maki, Ian, Johannessen, Jan, Estep, Scharla, Grigoriev, Yevgeny, Madenwald, Tamra, Hansen, Marianne, Holman, Drienna, Fair, Ramey, Meyer, Genevieve, Luke-Kilolam, Anya, Miner, Maurine D., deCamp, Allan, Grunenberg, Nicole, De Rosa, Stephen C., Fiore-Gartland, Andrew, Bar, Katherine, Spearman, Paul, Allen, Mary, Yu, Pei-Chun, Manso, Bryce, Frahm, Nicole, Kalams, Spyros, Baden, Lindsey, Keefer, Michael C., Scott, Hyman M., Novak, Richard, Van Tieu, Hong, Tomaras, Georgia D., Kublin, James G., McElrath, M. Juliana, Corey, Lawrence, and Frank, Ian

Published
2024
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16. Molecular detection of pre-ribosomal RNAs of Mycobacterium bovis bacille Calmette-Guérin and Mycobacterium tuberculosis to enhance pre-clinical tuberculosis drug and vaccine development

Author

Chang, Ming, Venkatasubramanian, Sambasivan, Barrett, Holly, Urdahl, Kevin B., Weigel, Kris M., Cangelosi, Gerard A., Shah, Javeed A., Saha, Aparajita, Feng, Libing, Adams, Kristin N., Sherman, David R., Smith, Nahum, Seshadri, Chetan, Kublin, James G., and Murphy, Sean C.

Published
2024
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17. Safety and immunogenicity of a subtype C ALVAC-HIV (vCP2438) vaccine prime plus bivalent subtype C gp120 vaccine boost adjuvanted with MF59 or alum in healthy adults without HIV (HVTN 107): A phase 1/2a randomized trial

Author

Moodie, Zoe, Andersen-Nissen, Erica, Grunenberg, Nicole, Dintwe, One B., Omar, Faatima Laher, Kee, Jia J., Bekker, Linda-Gail, Laher, Fatima, Naicker, Nivashnee, Jani, Ilesh, Mgodi, Nyaradzo M., Hunidzarira, Portia, Sebe, Modulakgota, Miner, Maurine D., Polakowski, Laura, Ramirez, Shelly, Nebergall, Michelle, Takuva, Simbarashe, Sikhosana, Lerato, Heptinstall, Jack, Seaton, Kelly E., De Rosa, Stephen, Diazgranados, Carlos A., Koutsoukos, Marguerite, Van Der Meeren, Olivier, Barnett, Susan W., Kanesa-thasan, Niranjan, Kublin, James G., Tomaras, Georgia D., McElrath, M. Juliana, Corey, Lawrence, Mngadi, Kathryn, and Goepfert, Paul

Subjects
Testing, Prevention, AIDS vaccines -- Testing, HIV infections -- Prevention, Immunologic adjuvants -- Testing, Immunological adjuvants -- Testing, HIV infection -- Prevention
Abstract

Author(s): Zoe Moodie 1,*, Erica Andersen-Nissen 1,2, Nicole Grunenberg 1, One B. Dintwe 1,2, Faatima Laher Omar 2, Jia J. Kee 1, Linda-Gail Bekker 3, Fatima Laher 4, Nivashnee Naicker [...], Background Adjuvants are widely used to enhance and/or direct vaccine-induced immune responses yet rarely evaluated head-to-head. Our trial directly compared immune responses elicited by MF59 versus alum adjuvants in the RV144-like HIV vaccine regimen modified for the Southern African region. The RV144 trial of a recombinant canarypox vaccine vector expressing HIV env subtype B (ALVAC-HIV) prime followed by ALVAC-HIV plus a bivalent gp120 protein vaccine boost adjuvanted with alum is the only trial to have shown modest HIV vaccine efficacy. Data generated after RV144 suggested that use of MF59 adjuvant might allow lower protein doses to be used while maintaining robust immune responses. We evaluated safety and immunogenicity of an HIV recombinant canarypox vaccine vector expressing HIV env subtype C (ALVAC-HIV) prime followed by ALVAC-HIV plus a bivalent gp120 protein vaccine boost (gp120) adjuvanted with alum (ALVAC-HIV+gp120/alum) or MF59 (ALVAC-HIV+gp120/MF59) or unadjuvanted (ALVAC-HIV+gp120/no-adjuvant) and a regimen where ALVAC-HIV+gp120 adjuvanted with MF59 was used for the prime and boost (ALVAC-HIV+gp120/MF59 coadministration). Methods and findings Between June 19, 2017 and June 14, 2018, 132 healthy adults without HIV in South Africa, Zimbabwe, and Mozambique were randomized to receive intramuscularly: (1) 2 priming doses of ALVAC-HIV (months 0 and 1) followed by 3 booster doses of ALVAC-HIV+gp120/MF59 (months 3, 6, and 12), n = 36; (2) 2 priming doses of ALVAC-HIV (months 0 and 1) followed by 3 booster doses of ALVAC-HIV+gp120/alum (months 3, 6, and 12), n = 36; (3) 4 doses of ALVAC-HIV+gp120/MF59 coadministered (months 0, 1, 6, and 12), n = 36; or (4) 2 priming doses of ALVAC-HIV (months 0 and 1) followed by 3 booster doses of ALVAC-HIV+gp120/no adjuvant (months 3, 6, and 12), n = 24. Primary outcomes were safety and occurrence and mean fluorescence intensity (MFI) of vaccine-induced gp120-specific IgG and IgA binding antibodies at month 6.5. All vaccinations were safe and well-tolerated; increased alanine aminotransferase was the most frequent related adverse event, occurring in 2 (1.5%) participants (1 severe, 1 mild). At month 6.5, vaccine-specific gp120 IgG binding antibodies were detected in 100% of vaccinees for all 4 vaccine groups. No significant differences were seen in the occurrence and net MFI of vaccine-specific IgA responses between the ALVAC-HIV+gp120/MF59-prime-boost and ALVAC-HIV+gp120/alum-prime-boost groups or between the ALVAC-HIV+gp120/MF59-prime-boost and ALVAC-HIV+gp120/MF59 coadministration groups. Limitations were the relatively small sample size per group and lack of evaluation of higher gp120 doses. Conclusions Although MF59 was expected to enhance immune responses, alum induced similar responses to MF59, suggesting that the choice between these adjuvants may not be critical for the ALVAC+gp120 regimen. Trial registration HVTN 107 was registered with the South African National Clinical Trials Registry (DOH-27-0715-4894) and ClinicalTrials.gov (NCT03284710).

Published
2024
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19. Risk of COVID-19 after natural infection or vaccination

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Adams, Atoya, Miller, Eric, Rankin, Bruce G., Shinn, Steven, Nash, Marshall, Green, Sinikka L., Jacobsen, Colleen, Krishnankutty, Jayasree, Phungwayo, Sikhongi, Glover, Richard M., II, Slechta, Stacy, Holdeman, Troy, Hartvickson, Robyn, Grant, Amber, Poling, Terry L., Klein, Terry D., Klein, Thomas C., Klein, Tracy R., Smith, William B., Gibson, Richard L., Winbigler, Jennifer, Parker, Elizabeth, Wijewardane, Priyantha N., Bravo, Eric, Thessing, Jeffrey, Maxwell, Michelle, Horn, Amanda, Healy, Catherine Mary, Akamine, Christine, Chu, Laurence, Chouteau, R. Michelle, Cotugno, Michael J., Bauer, George H., Jr., Hachigian, Greg, Oshita, Masaru, Cancilla, Michael, Kiersey, Kristen, Seger, William, Antwi, Mohammed, Green, Allison, Kim, Anthony, Desjardins, Michael, Johnson, Jennifer A., Sherman, Amy, Walsh, Stephen R., Borger, Judith, Saleem, Nafisa, Solis, Joel, Medina, Martha Carmen, Keating, Westly, Garcia, Edgar, Bueno, Cynthia, Segall, Nathan, Denham, Douglas S., Weiss, Thomas, Avworo, Ayoade, Hedges, Parke, Strout, Cynthia Becher, Santiago, Rica, Davis, Yvonne, Howenstine, Patty, Bondell, Alison, Marks, Kristin, Wang, Tina, Wilkin, Timothy, Vogler, Mary, Johnston, Carrie, Andrasik, Michele P., Andriesen, Jessica G., Broder, Gail, Eaton, Niles, Gelderblom, Huub G., McClennen, Rachael, Michael, Nelson, Robb, Merlin, Sopher, Carrie, Miller, Vicki E., Santiago, Fredric, Gomez, Blanca, Valika, Insiya, Starr, Amy, Cantos, Valeria D., Kandiah, Sheetal, Rio, Carlos del, Rouphael, Nadine, Edupuganti, Srilatha, Anderson, Evan J., Camacho-Gonzalez, Andres, Kamidani, Satoshi, Teherani, Meghan, Diemert, David J., Malkin, Elissa, Siegel, Marc, Roberts, Afsoon, Simon, Gary, Balani, Bindu, Stephenson, Carolene, Sperber, Steven, Cicogna, Cristina, Zervos, Marcus J., Kilgore, Paul, Ramesh, Mayur, Herc, Erica, Zenlea, Kate, Burgher, Abram, Milliken, Ann M., Davis, Joseph D., Levy, Brendan, Kelman, Sandra, Doust, Matthew W., Sample, Denise, Erickson, Sandra, Christensen, Shane G., Matich, Christopher, Longe, James, Witbeck, John, Peterson, James T., Clark, Alexander, Kelty, Gerald, Pena-Renteria, Issac, Koren, Michael J., Bartilucci, Darlene, Patel, Alpa, Tran, Carolyn, Kennelly, Christina, Brownlee, Robert, Coleman, Jacob, Webster, Hala, Fierro, Carlos A., Leistner, Natalia, Thompson, Amy, Gonzalez, Celia, Jackson, Lisa A., Suyehira, Janice, Haber, Milton, Regalado, Maria M., Procasky, Veronica, Lutat, Alisha, Griffin, Carl P., Hollister, Ripley R., Brown, Jeremy, Ronk, Melody, Harper, Wayne L., Cohen, Lisa, Eckert, Lynn, Hong, Matthew, Rouhbakhsh, Rambod, Danford, Elizabeth, Johnson, John, Calderone, Richard, Khetan, Shishir K., Olanrewaju, Oyebisi, Zhai, Nan, Nieves, Kimberly, O'Brien, Allison, Bradley, Paul S., Lilienthal, Amanda, Callis, Jim, Brosz, Adam B., Clement, Andrea, West, Whitney, Friesen, Luke, Cramer, Paul, Eder, Frank S., Little, Ryan, Engler, Victoria, Rattenbury-Shaw, Heather, Ensz, David J., Oplinger, Allie, Essink, Brandon J., Meyer, Jay, Raiser, Frederick, III, Mueller, Kimberly, Vrbicky, Keith W., Harper, Charles, Nutsch, Chelsie, Lewis, Wendell, III, Laflan, Cathy, Whatley, Jordan L., Harrell, Nicole, Shannon, Amie, Rowell, Crystal, Dedon, Christopher, Makhene, Mamodikoe, Gottschlich, Gregory M., Harden, Kate, Gottschlich, Melissa, Smith, Mary, Powell, Richard, Kimmel, Murray A., Pinto, Simmy, Vachris, Timothy P., Hutchens, Mark, Daniels, Stephen, Wells, Margaret, Van Der Leden, Mimi, Jackson-Booth, Peta-Gay, Baron, Mira, Kane, Pamela, Seversen, Shannen, Kryvicky, Mara, Lord, Julia, Saleh, Jamshid, Miles, Matthew, Lupercio, Rafael, McGettigan, John W., Jr., Patton, Walter, Brakema, Riemke, Choquette, Karin, McGettigan, Jonlyn, Kirstein, Judith L., Bernard, Marcia, Manning, Mary Beth, Rothenberg, Joan, Briskin, Toby, Roadman, Denise, Tedder-Edwards, Sharita, Schwartz, Howard I., Mederos, Surisday, Swaminathan, Shobha, Nyaku, Amesika, Varughese, Tilly, DallaPiazza, Michelle, Frey, Sharon E., Graham, Irene, Abate, Getahun, Hoft, Daniel, Allen, Leland N., III, Edwards, Leslie A., Davis, William S., Jr., Mena, Jessica M., Kutner, Mark E., Caso, Jorge, Moran, Maria Hernandez, Carvajal, Marianela, Mendez, Janet, Wadsworth, Larkin T., III, Adams, Michael R., Iverson, Leslie, Newberg, Joseph L., Pearlman, Laura, Nugent, Paul J., Reynolds, Michele D., Bashour, Jennifer, Schmidt, Robert, Sheth, Neil P., Steil, Kenneth, Toma, Ramy J., Kirby, William, Folmar, Pink, Williams, Samantha, Pickrell, Paul, Mott, Stefanie, Linebarger, Carol Ann, Malbari, Hussain, Pampe, David, Fragoso, Veronica G., Holloway, Lisa, McKeown-Bragas, Cecilia, Becker, Teresa, Williams, Barton G., Jones, William H., Clark, Jesse L., Shoptaw, Steven, Vertucci, Michele, Hernandez, Will, Spector, Stephen A., Moodley, Amaran, Blumenthal, Jill, Stangl, Lisa, Deutsch, Karen, Mullane, Kathleen M., Pitrak, David, Nuss, Cheryl, Pi, Judy, Fichtenbaum, Carl, Powers-Fletcher, Margaret, Saemann, Michelle, Kohrs, Sharon, Campbell, Thomas B., Lauria, Andrew, Mancilla, Jose C., Dunlevy, Hillary, Novak, Richard M., Wendrow, Andrea, Borgetti, Scott, Ladner, Ben, Chrisley, Lisa, Young, Cheryl, Doblecki-Lewis, Susanne, Alcaide, Maria L., Gonzales-Zamora, Jose, Morris, Stephen, Wohl, David, Eron, Joseph, Jr., Frank, Ian, Dunbar, Debora, Metzger, David, Momplaisir, Florence, Martin, Judith, Hoberman, Alejandro, Shope, Timothy, Muniz, Gysella, Rupp, Richard, Stanford, Amber, Berman, Megan, Porterfield, Laura, Lewis, Michael, Ghadishah, Elham, Yusin, Joseph, Pham, Mai, Creech, Clarence B., II, Walker, Shannon, Rolsma, Stephanie, Samuels, Robert, Thomsen, Isaac, Kalams, Spyros A., Wilson, Greg, Lucksinger, Gregg H., Parks, Kevin, Israelsen, Ryan, Ostovar, Jaleh, Kelly, Kary, Overcash, Jeffrey S., Chu, Hanh, Lee, Kia, De La Cruz, Luis I., Clemons, Steve, Everette, Elizabeth, Studdard, Suzanna, Mohan, Gowdhami, Tyson, Stefanie, Peay, Alyssa-Kay, Johnson, Danyel, Feldman, Gregory J., Suen, May-Yin, Muenzner, Jacqueline, Boscia, Joseph, Siddiqui, Farhan, Sanders, John, Peacock, James, Nasim, Julio, Levin, Michael L., Hussey, Julie, Kulic, Marcy, McKenzie, Mark M., Deese, Teresa, Osmundsen, Erica, Sweet, Christy, Ebuh, Valentine M., Elnagar, Elwaleed, Ebuh, Georgette, Iwuala, Genevieve, Han-Conrad, Laurie J., Simmons, Todd, Tarakjian, Denis, Ackermann, Jeremy, Adams, Mark S., Alemán, José O., Al-Ibrahim, Mohamed S., Andes, David R., Andrews, Jeb, Arduino, Roberto C., Bäcker, Martín, Badillo, Diana, Bainbridge, Emma, Batteiger, Teresa A., Bazan, Jose A., Bedimo, Roger J., Benitez, Jorge A., Bennett, Annette R., Bernstein, David I., Bialobok, Kristin, Boas, Rebecca, Brady, Judith, Brown, Cynthia, Bunce, Catherine A., Call, Robert S., Campbell, Wesley, Carmody, Ellie, Carpenter, Christopher, Carsons, Steven E., Castellon, Marvin, Castro, Mario, Catan, Hannah, Chang, Jennifer, Chebib, Mouna G., Chen, Corey M., Cheng, Margaret, Chow, Brian D.W., Ciambruschini, Annie, Connor, Joseph P., Conway, James H., Cooney, Maureen, Curlin, Marcel, De La Matta Rodriguez, Claudia, Dedon, Jon F., Degan, Emily, Dickey, Michelle, Dietz, Craig, Dong, Jennifer L., Dorcely, Brenda, Dube, Michael P., Dyer, Carmel B., Eckhardt, Benjamin, Ellerbeck, Edward, Ewers, Evan C., Falk, Amy, Feijoo, Brittany, Felsen, Uriel R., Fiel, Tom, Fitz-Patrick, David, Fogarty, Charles M., Ford, Stacy, Forero, Lina M., Formentini, Elizabeth, Franco-Vitteri, Doris, Frenck, Robert W., Jr., Gharib, Elie, Gharib, Suzanne, Rucker, Rola G., Goldenberg, James N., González, Luis H., Gray, Brett, Greene, Rusty, Grossberg, Robert M., Guanira-Carranza, Juan V., Guerreros Benavides, Alfredo Gilberto, Guillory, Clint C., Gunaratne, Shauna H., Halpert, David, Hamilton, Holli, Hartman, William R., Henderson, Sheryl L., Herati, Ramin, Guarin, Laura Hernandez, Hilder, Robin, Ho, Ken, Hojat, Leila, Hosek, Sybil G., Jacobson, Jeffrey M., Jay, Melanie, Johnson, Diane H., Jones, Kathleen S., Jones-López, Edward C., Justman, Jessica E., Kahney, Scott, Katz, Lois, Katz, Melinda, Kaul, Daniel, Keefer, Michael C., Kennedy, Ashley, Knishinsky, Jennifer, Kogelman, Laura, Koletar, Susan L., Kottkamp, Angelica, Laguio-Vila, Maryrose, Landovitz, Raphael J., Lee, Jessica L., Liu, Albert, Llerena Zegarra, Eneyda Giuvanela, Lok, Anna S., Lovell, James, Lubelchek, Ronald, Lucaj, John, Luckasen, Gary, Luetkemeyer, Annie, Lugogo, Njira Lucia, Maenza, Janine, Malvestutto, Carlos, Mauri, Monica, Maves, Ryan C., Mayer, Kenneth H., McCartney, Michael J., McCort, Margaret E., McElrath, M. Juliana, McNairy, Meredith, Merino, Fernando L., Meyerowitz, Eric A., Mitchell, Carol L., Monaco, Cynthia L., Muhammad, Sauda, Muñoz-Gómez, Sigridh, Munsiff, Sonal, Nee, Paul, Nollen, Nicole L., Noor, Asif, Lagos, Claudio Nuñez, Okulicz, Jason F., Oliver, Patrick A., Ortega, Jessica, Palmer, Steven, Parameswaran, Lalitha, Parikh, Purvi, Parker, Susan, Parungao, Reza, Pavie, Juana R., Madan, Rebecca P., Peralta, Henry, Petts, Jennifer, Pierce, Kristen K., Pretell Alva, E. Javier, Purpura, Lawrence J., Raabe, Vanessa, Recuenco, Sergio E., Richards, Tamara, Riddler, Sharon A., Rizzardi, Barbara, Rokser, Rachel, Rolle, Charlotte-Paige, Rosen, Adam, Rosen, Jeffrey, Freese, Lena R., Santolaya, María E., Schipani, Linda M., Schwartz, Adam, Schwasinger-Schmidt, Tiffany, Scott, Hyman, Sha, Beverly E., Shankaran, Shivanjali, Shapiro, Adrienne E., Sharp, Stephan C., Shopsin, Bo, Sims, Matthew D., Skipper, Stephanie, Smith, Derek M., Smith, Michael J., Sobhanie, M. Mahdee, Sovic, Brit, Sterling, Stephanie, Striker, Robert, Tafur Bances, Karla Beatriz, Talaat, Kawsar R., Tavel, Edward M., Jr., Tieu, Hong V., Tomaszewski, Christian, Tomlinson, Ryan, Torres, Juan P., Torres, Julian A., Treanor, John J., Tukuru, Sade, Ulrich, Robert J., Utz, Gregory C., Viar, Veronica, Viau Colindres, Roberto A., Walsh, Edward E., Walsh, Mary C., Walter, Emmanuel B., Weidler, Jessica L., Wu, Yi H., Yang, Kinara S., Yrivarren Giorza, Juan Luis, Zemanek, Arthur L., Zhang, Kevin, Zingman, Barry S., Gorman, Richard, Paez, Carmen A., Swann, Edith, Takuva, Simbarashe G., Greninger, Alex, Roychoudhury, Pavitra, Coombs, Robert W., Jerome, Keith R., Castellino, Flora, Tong, Xiaomi, Pavetto, Corrina, Gipson, Teletha, Tong, Tina, Lee, Marina, Zhou, James, Fay, Michael, McQuarrie, Kelly, Nnadi, Chimeremma, Sogbetun, Obiageli, Ahmad, Nina, De Proost, Ian, Hoseyni, Cyrus, Coplan, Paul, Khan, Najat, Ronco, Peter, Furey, Dawn, Meck, Jodi, Vingerhoets, Johan, Brandenburg, Boerries, Custers, Jerome, Hendriks, Jenny, Juraszek, Jarek, Marit de Groot, Anne, Van Roey, Griet, Heerwegh, Dirk, Van Dromme, Ilse, Méndez Galván, Jorge F., Carrascal, Monica B., Duran, Adriana Sordo, Sanchez Guerrero, Laura Ruy, Gómora Madrid, Martha Cecilia, Barrat Hernández, Alejandro Quintín, Guizar, Sharzhaad Molina, González Estrada, Denisse Alejandra, Martínez Pérez, Silvano Omar, Zárate Hinojosa, Zindy Yazmín, Ruiz-Palacios, Guillermo Miguel, Cruz-Valdez, Aurelio, Pacheco-Flores, Janeth, Lara, Anyela, Díaz-Miralrio, Secia, Reyes Fentanes, María José, Olmos Vega, Jocelyn Zuleica, Méndez, Daniela Pineda, Martínez, Karina Cano, Alvarez León, Winniberg Stephany, Ruiz Herrera, Vida Veronica, Vázquez Saldaña, Eduardo Gabriel, Camacho Choza, Laura Julia, Vega Orozco, Karen Sofia, Ortega Domínguez, Sandra Janeth, Chacón, Jorge A., Rivera, Juan J., Cutz, Erika A., Ortegón, Maricruz E., Rivera, María I., Browder, David, Burch, Cortney, Moye, Terri, Bondy, Paul, Browder, Lesley, Manning, Rickey D., Hurst, James W., Sturgeon, Rodney E., Wakefield, Paul H., Kirby, John A., Andersen, James, Fearon, Szheckera, Negron, Rosa, Medina, Amy, Hill, John M., Rajasekhar, Vivek, Williams, Hayes, Cade, LaShondra, Fouts, Rhodna, Moya, Connie, Anderson, Corey G., Devine, Naomi, Ramsey, James, Perez, Ashley, Tatelbaum, David, Jacobs, Michael, Menasche, Kathleen, Mirkil, Vincent, Winkle, Peter J., Haggag, Amina Z., Haynes, Michelle, Villegas, Marysol, Raja, Sabina, Riesenberg, Robert, Plavin, Stanford, Lerman, Mark, Woodside, Leana, Johnson, Maria, Healy, C. Mary, Whitaker, Jennifer A., Keitel, Wendy A., Atmar, Robert L., Horwith, Gary, Mason, Robin, Johnson, Lisa, Dora, Tambra, Murray, Deborah, Ledbetter, Logan, Ewing, Beverly, Stephenson, Kathryn E., Tan, Chen S., Zash, Rebecca, Ansel, Jessica L., Jaegle, Kate, Guiney, Caitlin J., Henderson, Jeffrey A., O'Leary, Marcia, Enright, Kendra, Kessler, Jill, Ducheneaux, Pete, Inniss, Asha, Brandon, Donald M., Davis, William B., Lawler, Daniel T., Oppong, Yaa D., Starr, Ryan P., Syndergaard, Scott N., Shelly, Rozeli, Majumder, Mashrur Islam, Sugimoto, Danny, Dugas, Jeffrey, Sr., Rijos, Dolores, Shelton, Sandra, Hong, Stephan, Schwartz, Howard, Sanchez-Crespo, Nelia, Schwartz, Jennifer, Piedra, Terry, Corral, Barbara, Medina, Carmen, Dever, Michael E., Shah, Mitul, Delgado, Michael, Scott, Tameika, Usdan, Lisa S., McGill, Lora J., Arnold, Valerie K., Scatamacchia, Carolyn, Anthony, Codi M., Merchant, Rajan, Yoon, Anelgine C., Hill, Janet, Ng-Price, Lucy, Thompson-Seim, Teri, Ackerman, Ronald, Ackerman, Jamie, Aristy, Florida, Ketter, Nzeera, Finley, Jon, Stull, Mildred, Murray, Monica, Rizvi, Zainab, Guerrero, Sonia, Paliwal, Yogesh K., Paliwal, Amit, Gordon, Sarah, Gordon, Bryan, Montano-Pereira, Cynthia, Galloway, Christopher, Montros, Candice, Aleman, Lily, Shairi, Samira, Van Ever, Wesley, Freeman, George H., Harmon, Esther L., Cross, Marshall A., Sales, Kacie, Gular, Catherine Q., Hepburn, Matthew, Alderson, Nathan, Harshell, Shana, Mahgoub, Siham, Maxwell, Celia, Mellman, Thomas, Thompson, Karl M., Wortman, Glenn, Kingsley, Jeff, Pixler, April, Curry, LaKondria, Afework, Sarah, Swanson, Austin, Jacqmein, Jeffry, Bowers, Maggie, Robison, Dawn, Mosteller, Victoria, Garvey, Janet, Easley, Mary, Kurnat, Rebecca J., Cornelison, Raymond, Gower, Shanda, Schnitz, William, Heinzig-Cartwright, Destiny S., Lewis, Derek, Newton, Fred E., Duhart, Aeiress, Watkins, Breanz, Ball, Brandy, York, Jill, Pickle, Shelby, Musante, David B., Silver, William P., Belhorn, Linda R., Viens, Nicholas A., Dellaero, David, Patel, Priti, Lisec, Kendra, Safirstein, Beth, Zapata, Luz, Gonzalez, Lazaro, Quevedo, Evelyn, Irani, Farah, Grillo, Joseph, Potts, Amy, White, Julie, Flume, Patrick, Headden, Gary, Taylor, Brandie, Warden, Ashley, Chamberlain, Amy, Jeanfreau, Robert, Jeanfreau, Susan, Matherne, Paul G., Caldwell, Amy, Stahl, Jessica, Vowell, Mandy, Newhouse, Lauren, Berthaud, Vladimir, Takizala, Zudi-Mwak, Beninati, Genevieve, Snell, Kimberly, Baker, Sherrie, Walker, James, Harrison, Tavane, Miller, Meagan, Otto, Janet, Gray, Roni, Wilson, Christine, Nemecek, Tiffany, Harrington, Hannah, Eppenbach, Sally, Lewis, Wendell, Bourgeois, Tana, Folsom, Lyndsea, Holt, Gregory, Mirsaeidi, Mehdi, Calderon, Rafael, Lichtenberger, Paola, Quintero, Jalima, Martinez, Becky, Immergluck, Lilly, Johnson, Erica, Chan, Austin, Fas, Norberto, Thomas-Seaton, LaTeshia, Khizer, Saadia, Staben, Jonathan, Beresnev, Tatiana, Jahromi, Maryam, Marovich, Mary A., Hutter, Julia, Nason, Martha, Ledgerwood, Julie, Mascola, John, Leibowitz, Mark, Morales, Fernanda, Delgado, Mike, Sanchez, Rosario, Vega, Norma, Áñez, Germán, Albert, Gary, Coston, Erin, Desai, Chinar, Dunbar, Haoua, Eickhoff, Mark, Garcia, Jenina, Kautz, Margaret, Lee, Angela, Lewis, Maggie, McGarry, Alice, McKnight, Irene, Nelson, Joy, Newingham, Patrick, Price-Abbott, Patty, Reed, Patty, Vegas, Diana, Wilkinson, Bethanie, Smith, Katherine, Woo, Wayne, Cho, Iksung, Glenn, Gregory M., Dubovsky, Filip, Fried, David L., Haughey, Lynne A., Stanton, Ariana C., Rameaka, Lisa Stevens, Rosenberg, David, Tomatsu, Lee, Gonzalez, Viviana, Manalo, Millie, Grunstra, Bernard, Quinn, Donald, Claybrook, Phillip, Olds, Shelby, Dye, Amy, Cannon, Kevin D., Chadwick, Mesha M., Jordan, Bailey, Hussey, Morgan, Nevarez, Hannah, Kelley, Colleen F., Chung, Michael, Moran, Caitlin, Rebolledo, Paulina, Bacher, Christina, Barranco-Santana, Elizabeth, Rodriguez, Jessica, Mendoza, Rafael, Ruperto, Karen, Olivieri, Odette, Ocaña, Enrique, Wylie, Paul E., Henderson, Renea, Jenson, Natasa, Yang, Fan, Kelley, Amy, Finkelstein, Kenneth, Beckmann, David, Hutchins, Tanya, Escallon, Sebastian Garcia, Johnson, Kristen, Sligh, Teresa S., Desai, Parul, Huynh, Vincent, Lopez, Carlos, Mendoza, Erika, Adelglass, Jeffrey, Naifeh, Jerome G., Kucera, Kristine J., Chughtai, Waseem, Jaffer, Shireen H., Davis, Matthew G., Foley, Jennifer, Burgett, Michelle L., Shlotzhauer, Tammi L., Ingalsbe-Geno, Sarah M., Duncanson, Daniel, Kush, Kelly, Nesbitt, Lori, Sonnier, Cora, McCarter, Jennifer, Butcher, Michael B., Fry, James, Percy, Donna, Freudemann, Karen, Gebhardt, Bruce C., Mangu, Padma N., Schroeck, Debra B., Davit, Rajesh K., Hennekes, Gayle D., Luft, Benjamin J., Carr, Melissa, Nachman, Sharon, Pellecchia, Alison, Smith, Candace, Valenti, Bruno, Bermudez, Maria I., Peraita, Noris, Delgado, Ernesto, Arrazcaeta, Alicia, Ramirez, Natalie, Amador, Carmen, Marafioti, Horacio, Dang, Lyly, Clement, Lauren, Berry, Jennifer, Allaw, Mohammed, Geuss, Georgettea, Miles, Chelsea, Bittner, Zachary, Werne, Melody, Calinescu, Cornell, Rodman, Shannon, Rindt, Joshua, Cooksey, Erin, Harrison, Kristina, Cooper, Deanna, Horton, Manisha, Philyaw, Amanda, Jennings, William, Alvarado, Hilario, Baka, Michele, Regalado, Malina, Murray, Linda, Naguib, Sherif, Singletary, Justin, Richmond, Sha-Wanda, Omodele, Sarah, Oppenheim, Emily, Martinez, Reuben, Andriulis, Victoria, Singer, Leonard, Blevins, Jeanne, Thomas, Meagan, Hull, Christine, Pereira, Isabel, Rivero, Gina, Okonya, Tracy, Downing, Frances, Miller, Paulina, Rhee, Margaret, Stapleton, Katherine, Klein, Jeffrey, Hong, Rosamond, Swan, Suzanne, Wahlin, Tami, Bennett, Elizabeth, Salzl, Amy, Phan, Sharine, White, Jewel J., Occhino, Amanda, Paiano, Ruth, McLaughlin, Morgan, Swieboda, Elisa, Garcia-Fragoso, Veronica, Becerra, Maria G., White, Toni, Turley, Christine B., McWilliams, Andrew, Esinhart, Tiffany, Montoya, Natasha, Huskey, Shamika, Paul, Leena, Tashima, Karen, Johnson, Jennie, 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Hasan, Florescu, Diana F., Starlin, Richard, Kline, David, Zimmer, Andrea, Abbas, Anum, Wilson, Natasha, Eron, Joseph J., Sciaudone, Michael, Rosengren, A. Lina, Kizer, John S., Rutstein, Sarah E., Bruce, Elizabeth, Espinosa, Claudia, Sanders, Lisa J., Kim, Kami, Casey, Denise, Taylor, Barbara S., Patterson, Thomas, Pinilla, Ruth S., Bullock, Delia, Ponce, Philip, Patterson, Jan, McClelland, R. Scott, Lane, Dakotah C., Wald, Anna, James, Frank, Duke, Elizabeth, Hauge, Kirsten, Heimonen, Jessica, Goecker, Erin A., Huang, Yunda, Fong, Youyi, Kauffman, Carol, Linder, Kathleen, Nofz, Kimberly, McConnell, Andrew, Buynak, Robert J., Webb, Angella, Petty, Taryn, Andree, Stephanie, Sanchez, Erica, Mackey, Nolan, Baudelaire, Clarisse, Dzigiel, Sarah, Marquez, Adrienna, Quillin, Kim, King, Michelle, Abad, Vanessa, Knowles, Jennifer, Waters, Michael, Zepeda, Karla, Coslet, Jordan, Tovar, Dalia, Shaw, Marian E., Turner, Mark A., Huffine, Cory J., Huffine, Esther S., Ake, Julie A., Secord, Elizabeth, McGrath, Eric, Levy, Phillip, Stewart, Brittany, Cromer, Charnell, Walters, Ayanna, Ellsworth, Grant, Greene, Caroline, Galloway, Sarah, Kapadia, Shashi, DeHaan, Elliot, Wilson, Clint, Milligan, Jason, Raley, Danielle, Bocchini, Joseph, McClenathan, Bruce, Hussain, Mary, Lomasney, Evelyn, Hall, Evelyn, Lamberth, Sherry, Schmeck, Christy, Leathers, Vickie, Theodore, Deborah A., Branche, Angela R., Graciaa, Daniel S., Hatlen, Timothy J., Miller, Jacqueline, Sadoff, Jerald, Falsey, Ann R., Sobieszczyk, Magdalena E., Rick, Anne-Marie, Laurens, Matthew B., Huang, Ying, Yu, Chenchen, Martin, Thomas C.S., Rodriguez, Carina A., Rostad, Christina A., Maboa, Rebone M., Baden, Lindsey R., El Sahly, Hana M., Grinsztejn, Beatriz, Gray, Glenda E., Gay, Cynthia L., Gilbert, Peter B., Janes, Holly E., Kublin, James G., Leav, Brett, Hirsch, Ian, Struyf, Frank, Dunkle, Lisa M., Neuzil, Kathleen M., Corey, Lawrence, Goepfert, Paul A., Follmann, Dean, and Kotloff, Karen L.

Published
2023
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20. Immune correlates analysis of the ENSEMBLE single Ad26.COV2.S dose vaccine efficacy clinical trial

Author

Fong, Youyi, McDermott, Adrian B., Benkeser, David, Roels, Sanne, Stieh, Daniel J., Vandebosch, An, Le Gars, Mathieu, Van Roey, Griet A., Houchens, Christopher R., Martins, Karen, Jayashankar, Lakshmi, Castellino, Flora, Amoa-Awua, Obrimpong, Basappa, Manjula, Flach, Britta, Lin, Bob C., Moore, Christopher, Naisan, Mursal, Naqvi, Muhammed, Narpala, Sandeep, O’Connell, Sarah, Mueller, Allen, Serebryannyy, Leo, Castro, Mike, Wang, Jennifer, Petropoulos, Christos J., Luedtke, Alex, Hyrien, Ollivier, Lu, Yiwen, Yu, Chenchen, Borate, Bhavesh, van der Laan, Lars W. P., Hejazi, Nima S., Kenny, Avi, Carone, Marco, Wolfe, Daniel N., Sadoff, Jerald, Gray, Glenda E., Grinsztejn, Beatriz, Goepfert, Paul A., Little, Susan J., Paiva de Sousa, Leonardo, Maboa, Rebone, Randhawa, April K., Andrasik, Michele P., Hendriks, Jenny, Truyers, Carla, Struyf, Frank, Schuitemaker, Hanneke, Douoguih, Macaya, Kublin, James G., Corey, Lawrence, Neuzil, Kathleen M., Carpp, Lindsay N., Follmann, Dean, Gilbert, Peter B., Koup, Richard A., and Donis, Ruben O.

Published
2022
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23. Developing tuberculosis vaccines for people with HIV: consensus statements from an international expert panel

Author

Miner, Maurine D, Hatherill, Mark, Mave, Vidya, Gray, Glenda E, Nachman, Sharon, Read, Sarah W, White, Richard G, Hesseling, Anneke, Cobelens, Frank, Patel, Sheral, Frick, Mike, Bailey, Theodore, Seder, Robert, Flynn, Joanne, Rengarajan, Jyothi, Kaushal, Deepak, Hanekom, Willem, Schmidt, Alexander C, Scriba, Thomas J, Nemes, Elisa, Andersen-Nissen, Erica, Landay, Alan, Dorman, Susan E, Aldrovandi, Grace, Cranmer, Lisa M, Day, Cheryl L, Garcia-Basteiro, Alberto L, Fiore-Gartland, Andrew, Mogg, Robin, Kublin, James G, Gupta, Amita, and Churchyard, Gavin

Published
2022
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24. Association Between SARS-CoV-2 Viral Load and COVID-19 Vaccination in 4 Phase 3 Trials.

Author

Janes, Holly, Fisher, Leigh H, Kee, Jia Jin, Parameswaran, Lalitha, Goepfert, Paul A, Falsey, Ann R, Ludwig, James, Magaret, Craig A, Gilbert, Peter B, Kublin, James G, Rouphael, Nadine, Sobieszczyk, Magdalena E, Sahly, Hana M El, Baden, Lindsey R, Grinsztejn, Beatriz, Walsh, Stephen R, Gray, Glenda E, Kotloff, Karen L, Gay, Cynthia L, and Greninger, Alexander L

Subjects
SARS-CoV-2, COVID-19, CLINICAL trial registries, CLINICAL trials, COVID-19 vaccines
Abstract

Coronavirus disease 2019 (COVID-19) vaccines reduce severe disease and mortality and may lessen transmission, measured by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral load (VL). Evaluating vaccine associations in VL at COVID-19 diagnosis in 4 phase 3 randomized, placebo-controlled vaccine trials, July 2020 to July 2021, VL reductions were 2.78 log10 copies/mL (95% confidence interval [CI], 1.38–4.18; n = 60 placebo, 11 vaccine) and 2.12 log10 copies/mL (95% CI, 1.44–2.80; n = 594 placebo, 36 vaccine) for NVX-CoV2373 and mRNA-1273, respectively. Associations were not significant for AZD1222 (0.59 log10 copies/mL; 95% CI, −.19 to 1.36; n = 90 placebo, 78 vaccine) or Ad26.COV2.S (0.23 log10 copies/mL; 95% CI, −.01 to.47; n = 916 placebo, 424 vaccine). Thus, vaccines potentially decreased transmission when ancestral SARS-CoV-2 predominated. Clinical Trials Registration. NCT04470427, NCT04505722, NCT04516746, NCT04611802. [ABSTRACT FROM AUTHOR]

Published
2024
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25. Non-HIV Vaccine-Induced Immune Responses as Potential Baseline Immunogenicity Predictors of ALVAC-HIV and AIDSVAX B/E-Induced Immune Responses.

Author

Huang, Ying, Alam, Shomoita, Andersen-Nissen, Erica, Carpp, Lindsay N., Dintwe, One B., Flach, Britta S., Grunenberg, Nicole, Laher, Fatima, De Rosa, Stephen C., Ferrari, Guido, Innes, Craig, Bekker, Linda-Gail, Kublin, James G., McElrath, M. Juliana, Tomaras, Georgia D., Gray, Glenda E., and Gilbert, Peter B.

Subjects
HEPATITIS associated antigen, AIDS vaccines, TETANUS vaccines, HEPATITIS B vaccines, VACCINE effectiveness, HEPATITIS B virus
Abstract

Identifying correlations between immune responses elicited via HIV and non-HIV vaccines could aid the search for correlates of HIV protection and increase statistical power in HIV vaccine-efficacy trial designs. An exploratory objective of the HVTN 097 phase 1b trial was to assess whether immune responses [focusing on those supported as correlates of risk (CoR) of HIV acquisition] induced via the RV144 pox-prime HIV vaccine regimen correlated with those induced via tetanus toxoid (TT) and/or hepatitis B virus (HBV) vaccines. We measured TT-specific and HBV-specific IgG-binding antibody responses and TT-specific and HBV-specific CD4+ T-cell responses at multiple time points in HVTN 097 participants, and we assessed their correlations at peak time points with HIV vaccine (ALVAC-HIV and AIDSVAX B/E)-induced responses. Four correlations were significant [false discovery rate-adjusted p-value (FDR) ≤ 0.2]. Three of these four were with IgG-binding antibody responses to TT measured one month after TT receipt, with the strongest and most significant correlation [rho = 0.368 (95% CI: 0.096, 0.588; p = 0.008; FDR = 0.137)] being with IgG-binding antibody responses to MN gp120 gDneg (B protein boost) measured two weeks after the second ALVAC-HIV and AIDSVAX B/E boost. The fourth significant correlation [(rho = 0.361; 95% CI: 0.049, 0.609; p = 0.021; FDR = 0.137)] was between CD4+ T-cell responses to a hepatitis B surface antigen peptide pool, measured 2 weeks after the third HBV vaccination, and IgG-binding antibody responses to gp70BCaseAV1V2 (B V1V2 immune correlate), measured two weeks after the second ALVAC-HIV and AIDSVAX B/E boost. These moderate correlations imply that either vaccine, TT or HBV, could potentially provide a moderately useful immunogenicity predictor for the ALVAC-HIV and AIDSVAX B/E HIV vaccine regimen. [ABSTRACT FROM AUTHOR]

Published
2024
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26. Safety and immunogenicity of two heterologous HIV vaccine regimens in healthy, HIV-uninfected adults (TRAVERSE): a randomised, parallel-group, placebo-controlled, double-blind, phase 1/2a study

Author

Ake, Julie A., Buchbinder, Susan, Buleza, Karen, Cohen, Kristen W., Crowell, Trevor A., Euler, Zelda, Frank, Ian, Goedhart, Dimitri, Keefer, Michael, Kelly, Colleen, Mayer, Ken, Nkolola, Joseph, Peter, Lauren, Robb, Merlin L., Rouphael, Nadine, Scheppler, Lorenz, Sobieszczyk, Magda, Van Tieu, Hong, Baden, Lindsey R, Stieh, Daniel J, Sarnecki, Michal, Walsh, Stephen R, Tomaras, Georgia D, Kublin, James G, McElrath, M Juliana, Alter, Galit, Ferrari, Guido, Montefiori, David, Mann, Philipp, Nijs, Steven, Callewaert, Katleen, Goepfert, Paul, Edupuganti, Srilatha, Karita, Etienne, Langedijk, Johannes P, Wegmann, Frank, Corey, Lawrence, Pau, Maria G, Barouch, Dan H, Schuitemaker, Hanneke, and Tomaka, Frank

Published
2020
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27. A phase 1b randomized study of the safety and immunological responses to vaccination with H4:IC31, H56:IC31, and BCG revaccination in Mycobacterium tuberculosis-uninfected adolescents in Cape Town, South Africa

Author

Bekker, Linda-Gail, Dintwe, One, Fiore-Gartland, Andrew, Middelkoop, Keren, Hutter, Julia, Williams, Anthony, Randhawa, April K., Ruhwald, Morten, Kromann, Ingrid, Andersen, Peter L., DiazGranados, Carlos A., Rutkowski, Kathryn T., Tait, Dereck, Miner, Maurine D., Andersen-Nissen, Erica, De Rosa, Stephen C., Seaton, Kelly E., Tomaras, Georgia D., McElrath, M. Juliana, Ginsberg, Ann, and Kublin, James G.

Published
2020
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28. Factors associated with reactogenicity to an investigational HIV vaccine regimen in HIV vaccine trials network 702

Author

Chihana, Rachel, primary, Jin Kee, Jia, additional, Moodie, Zoe, additional, Huang, Yunda, additional, Janes, Holly, additional, Dadabhai, Sufia, additional, Roxby, Alison C., additional, Allen, Mary, additional, Kassim, Sheetal, additional, Naicker, Vimla, additional, Innes, Craig, additional, Naicker, Nivashnee, additional, Dubula, Thozama, additional, Grunenberg, Nicole, additional, Malahleha, Mookho, additional, Kublin, James G., additional, Bekker, Linda-Gail, additional, Gray, Glenda, additional, Kumwenda, Johnstone, additional, and Laher, Fatima, additional

Published
2024
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29. COVID-19 vaccine efficacy in participants with weakened immune systems from four randomized-controlled trials

Author

Sherman, Amy, primary, Tuan, Jessica, additional, Cantos, Valeria D, additional, Adeyiga, Oladunni, additional, Mahoney, Scott, additional, Ortega-Villa, Ana M, additional, Tillman, Amy, additional, Whitaker, Jennifer, additional, Woodward Davis, Amanda S, additional, Leav, Brett, additional, Hirsch, Ian, additional, Sadoff, Jerald, additional, Dunkle, Lisa M, additional, Gilbert, Peter B, additional, Janes, Holly E, additional, Kublin, James G, additional, Goepfert, Paul A, additional, Kotloff, Karen, additional, Rouphael, Nadine, additional, Falsey, Ann R, additional, El Sahly, Hana M, additional, Sobieszczyk, Magdalena E, additional, Huang, Yunda, additional, Neuzil, Kathleen M, additional, Corey, Lawrence, additional, Grinsztejn, Beatriz, additional, Gray, Glenda, additional, Nason, Martha, additional, Baden, Lindsey R, additional, and Gay, Cynthia L, additional

Published
2024
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30. Safety and immunogenicity of a multivalent HIV vaccine comprising envelope protein with either DNA or NYVAC vectors (HVTN 096): a phase 1b, double-blind, placebo-controlled trial

Author

Pantaleo, Giuseppe, Janes, Holly, Karuna, Shelly, Grant, Shannon, Ouedraogo, G Laissa, Allen, Mary, Tomaras, Georgia D, Frahm, Nicole, Montefiori, David C, Ferrari, Guido, Ding, Song, Lee, Carter, Robb, Merlin L, Esteban, Mariano, Wagner, Ralf, Bart, Pierre-Alexandre, Rettby, Nils, McElrath, M Juliana, Gilbert, Peter B, Kublin, James G, and Corey, Lawrence

Published
2019
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31. Polytopic fractional delivery of an HIV vaccine alters cellular responses and results in increased epitope breadth in a phase 1 randomized trial

Author

Miner, Maurine D., primary, deCamp, Allan, additional, Grunenberg, Nicole, additional, De Rosa, Stephen C., additional, Fiore-Gartland, Andrew, additional, Bar, Katherine, additional, Spearman, Paul, additional, Allen, Mary, additional, Yu, Pei-Chun, additional, Manso, Bryce, additional, Frahm, Nicole, additional, Kalams, Spyros, additional, Baden, Lindsey, additional, Keefer, Michael C., additional, Scott, Hyman M., additional, Novak, Richard, additional, Van Tieu, Hong, additional, Tomaras, Georgia D., additional, Kublin, James G., additional, McElrath, M. Juliana, additional, Corey, Lawrence, additional, Frank, Ian, additional, Kalichman, Artur, additional, Edlefsen, Paul, additional, Enama, Mary, additional, Hural, John, additional, Holt, Renee, additional, Dunbar, Debora, additional, Crawford, Dave, additional, Maki, Ian, additional, Johannessen, Jan, additional, Estep, Scharla, additional, Grigoriev, Yevgeny, additional, Madenwald, Tamra, additional, Hansen, Marianne, additional, Holman, Drienna, additional, Fair, Ramey, additional, Meyer, Genevieve, additional, and Luke-Kilolam, Anya, additional

Published
2024
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32. Pre-HIV α4ꞵ7hi CD4  T Cells and the Risk of Heterosexual HIV Acquisition and Progression in African Individuals: A Multi-Cohort Case-Control Study

Author

Omole, Tosin, primary, Nguyen, Huong Mai, additional, Marcinow, Agata, additional, Oo, Myo Minn, additional, Jahan, Naima, additional, Ssemaganda, Aloysious, additional, Severini, Giulia, additional, Thomas, Katherine, additional, Celum, Connie L., additional, Mugo, Nelly R., additional, Mujugira, Andrew, additional, Kublin, James G., additional, Lawrence, Corey, additional, Sivro, Aida, additional, Lingappa, Jairam R., additional, Gray, Glenda, additional, and McKinnon, Lyle, additional

Published
2024
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34. The HVTN503/Phambili HIV vaccine trial: a comparison of younger and older participants

Author

Volk, Jonathan E, Hessol, Nancy A, Gray, Glenda E, Kublin, James G, Churchyard, Gavin J, Mlisana, Koleka, Nchabeleng, Maphoshane, Buchbinder, Susan P, and Bekker, Linda-Gail

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Sexually Transmitted Infections, Vaccine Related, Clinical Trials and Supportive Activities, Patient Safety, Clinical Research, Infectious Diseases, Prevention, Immunization, HIV/AIDS, Aging, 6.1 Pharmaceuticals, Good Health and Well Being, AIDS Vaccines, Adolescent, Adult, Age Distribution, Clinical Trials as Topic, Female, HIV Infections, Humans, Male, Motivation, Patient Participation, Patient Selection, South Africa, Young Adult, HIV, AIDS, prevention, vaccination, vaccine trials, clinical trials, youth, Medical Microbiology, Public Health and Health Services, Public Health, Clinical sciences, Immunology
Abstract

By comparing younger to older participants enrolled in a HIV vaccine efficacy trial, we aimed to gain insights into the inclusion of adolescents in future trials. This was a sub-analysis of a multisite HIV vaccine randomized clinical trial in South Africa, conducted January-September 2007. Motivations for trial enrolment, social harms, adverse events and loss to follow-up were compared between younger (18-20 years old) and older participants (21-35 years old). Both younger (n = 238) and older participants (n = 563) were equally likely to report enrolling for altruistic reasons. Younger females were less likely than older participants to join for trial reimbursement (p = 0.005), while younger males were more likely to enrol because the vaccine may provide protection from HIV-acquisition (p < 0.001). There were no significant differences in the number of social harms reported. Compared to males over 20 years old, 18-20-year-old females were less likely to experience adverse events (OR = 0.1, CI 0.01-0.80) and no more likely to be lost to follow-up (OR = 0.7, CI 0.39-1.25), while 18-20-year-old males were no more likely to experience adverse events (OR = 1.3, CI 0.58-2.83) or loss to follow-up (OR = 0.8, CI 0.51-1.41). Our data support the inclusion of younger participants who are at risk for HIV in future HIV vaccine efficacy trials.

Published
2014

35. COVID-19 Vaccine Efficacy in Participants With Weakened Immune Systems From 4 Randomized Controlled Trials.

Author

Sherman, Amy C, Tuan, Jessica, Cantos, Valeria D, Adeyiga, Oladunni, Mahoney, Scott, Ortega-Villa, Ana M, Tillman, Amy, Whitaker, Jennifer, Davis, Amanda S Woodward, Leav, Brett, Hirsch, Ian, Sadoff, Jerald, Dunkle, Lisa M, Gilbert, Peter B, Janes, Holly E, Kublin, James G, Goepfert, Paul A, Kotloff, Karen, Rouphael, Nadine, and Falsey, Ann R

Subjects
NUTRITION disorders, PLACEBOS, VACCINE effectiveness, IMMUNOCOMPROMISED patients, STATISTICAL sampling, IMMUNE system, COVID-19 vaccines, RANDOMIZED controlled trials, PHARMACEUTICAL industry
Abstract

Background Although the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines are highly efficacious at preventing severe disease in the general population, current data are lacking regarding vaccine efficacy (VE) for individuals with mild immunocompromising conditions. Methods A post hoc, cross-protocol analysis of participant-level data from the blinded phase of four randomized, placebo-controlled, coronavirus disease 2019 (COVID-19) vaccine phase 3 trials (Moderna, AstraZeneca, Janssen, and Novavax) was performed. We defined a "tempered immune system" (TIS) variable via a consensus panel based on medical history and medications to determine VE against symptomatic and severe COVID-19 cases in TIS participants versus non-TIS individuals starting at 14 days after completion of the primary series through the blinded phase for each of the 4 trials. An analysis of participants living with well-controlled human immunodeficiency virus was conducted using the same methods. Results A total of 3852/30 351 (12.7%) Moderna participants, 3088/29 868 (10.3%) Novavax participants, 3549/32 380 (11.0%) AstraZeneca participants, and 5047/43 788 (11.5%) Janssen participants were identified as having a TIS. Most TIS conditions (73.9%) were due to metabolism and nutritional disorders. Vaccination (vs placebo) significantly reduced the likelihood of symptomatic and severe COVID-19 for all participants for each trial. VE was not significantly different for TIS participants versus non-TIS for either symptomatic or severe COVID-19 for each trial, nor was VE significantly different in the symptomatic endpoint for participants with human immunodeficiency virus. Conclusions For individuals with mildly immunocompromising conditions, there is no evidence of differences in VE against symptomatic or severe COVID-19 compared with those with non-TIS in the 4 COVID-19 vaccine randomized controlled efficacy trials. [ABSTRACT FROM AUTHOR]

Published
2024
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36. Review of Current Tuberculosis Human Infection Studies for Use in Accelerating Tuberculosis Vaccine Development: A Meeting Report.

Author

Balasingam, Shobana, Dheda, Keertan, Fortune, Sarah, Gordon, Stephen B, Hoft, Daniel, Kublin, James G, Loynachan, Colleen N, McShane, Helen, Morton, Ben, Nambiar, Sujatha, Sharma, Nimisha Raj, Robertson, Brian, Schrager, Lewis K, and Weller, Charlotte L

Subjects
VACCINE development, TUBERCULOSIS vaccines, BCG vaccines, AIDS vaccines, DRUG development
Abstract

Tools to evaluate and accelerate tuberculosis (TB) vaccine development are needed to advance global TB control strategies. Validated human infection studies for TB have the potential to facilitate breakthroughs in understanding disease pathogenesis, identify correlates of protection, develop diagnostic tools, and accelerate and de-risk vaccine and drug development. However, key challenges remain for realizing the clinical utility of these models, which require further discussion and alignment among key stakeholders. In March 2023, the Wellcome Trust and the International AIDS Vaccine Initiative convened international experts involved in developing both TB and bacillus Calmette-Guérin (BCG) human infection studies (including mucosal and intradermal challenge routes) to discuss the status of each of the models and the key enablers to move the field forward. This report provides a summary of the presentations and discussion from the meeting. Discussions identified key issues, including demonstrating model validity, to provide confidence for vaccine developers, which may be addressed through demonstration of known vaccine effects (eg, BCG vaccination in specific populations), and by comparing results from field efficacy and human infection studies. The workshop underscored the importance of establishing safe and acceptable studies in high-burden settings, and the need to validate >1 model to allow for different scientific questions to be addressed as well as to provide confidence to vaccine developers and regulators around use of human infection study data in vaccine development and licensure pathways. [ABSTRACT FROM AUTHOR]

Published
2024
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37. A Randomized Trial Evaluating the Prophylactic Activity of DSM265 Against Preerythrocytic Plasmodium falciparum Infection During Controlled Human Malarial Infection by Mosquito Bites and Direct Venous Inoculation

Author

Murphy, Sean C., Duke, Elizabeth R., Shipman, Kelly J., Jensen, Ryan L., Fong, Youyi, Ferguson, Sue, Janes, Holly E., Gillespie, Kevin, Seilie, Annette M., Hanron, Amelia E., Rinn, Laurie, Fishbaugher, Matthew, VonGoedert, Tracie, Fritzen, Emma, Kappe, Stefan H., Chang, Ming, Sousa, Jason C., Marcsisin, Sean R., Chalon, Stephan, Duparc, Stephan, Kerr, Nicola, Möhrle, Jörg J., Andenmatten, Nicole, Rueckle, Thomas, and Kublin, James G.

Published
2018

38. Subtype C ALVAC-HIV and bivalent subtype C gp120/MF59 HIV-1 vaccine in low-risk, HIV-uninfected, South African adults: a phase 1/2 trial

Author

Bekker, Linda-Gail, Moodie, Zoe, Grunenberg, Nicole, Laher, Fatima, Tomaras, Georgia D, Cohen, Kristen W, Allen, Mary, Malahleha, Mookho, Mngadi, Kathryn, Daniels, Brodie, Innes, Craig, Bentley, Carter, Frahm, Nicole, Morris, Daryl E, Morris, Lynn, Mkhize, Nonhlanhla N, Montefiori, David C, Sarzotti-Kelsoe, Marcella, Grant, Shannon, Yu, Chenchen, Mehra, Vijay L, Pensiero, Michael N, Phogat, Sanjay, DiazGranados, Carlos A, Barnett, Susan W, Kanesa-thasan, Niranjan, Koutsoukos, Marguerite, Michael, Nelson L, Robb, Merlin L, Kublin, James G, Gilbert, Peter B, Corey, Lawrence, Gray, Glenda E, and McElrath, M Juliana

Published
2018
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39. Efficacy of Messenger RNA–1273 Against Severe Acute Respiratory Syndrome Coronavirus 2 Acquisition in Young Adults From March to December 2021

Author

Stephenson, Kathryn E, primary, Marcelin, Jasmine R, additional, Pettifor, Audrey E, additional, Janes, Holly, additional, Brown, Elizabeth, additional, Neradilek, Moni, additional, Yen, Catherine, additional, Andriesen, Jessica, additional, Grunenberg, Nicole, additional, Espy, Nicole, additional, Trahey, Meg, additional, Fischer, Rebecca S B, additional, DeSouza, Christopher A, additional, Shisler, Joanna L, additional, Connick, Elizabeth, additional, Houpt, Eric R, additional, Chu, Helen Y, additional, McCulloh, Russel J, additional, Becker-Dreps, Sylvia, additional, Vielot, Nadja A, additional, Kalbaugh, Corey A, additional, Cherabuddi, Kartik, additional, Krueger, Karen M, additional, Rosenberg, Molly, additional, Greenberg, Richard N, additional, Joaquin, Arnel, additional, Immergluck, Lilly Cheng, additional, Corey, Lawrence, additional, and Kublin, James G, additional

Published
2023
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40. The Regulation of Nucleic Acid Vaccine Responses by the Microbiome

Author

Johnson, Andrew M. F., primary, Hager, Kevin, additional, Alameh, Mohamad-Gabriel, additional, Van, Phuong, additional, Potchen, Nicole, additional, Mayer-Blackwell, Koshlan, additional, Fiore-Gartland, Andrew, additional, Minot, Samuel, additional, Lin, Paulo J. C., additional, Tam, Ying K., additional, Weissman, Drew, additional, and Kublin, James G., additional

Published
2023
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41. Molecular detection of pre-ribosomal RNAs of Mycobacterium bovis Bacille Calmette-Guérin and Mycobacterium tuberculosis to enhance pre-clinical tuberculosis drug and vaccine development

Author

Chang, Ming, primary, Venkatasubramanian, Sambasivan, additional, Barrett, Holly, additional, Urdahl, Kevin B., additional, Weigel, Kris M., additional, Cangelosi, Gerard A., additional, Shah, Javeed A., additional, Saha, Aparajita, additional, Feng, Libing, additional, Adams, Kristin N., additional, Sherman, David R., additional, Smith, Nahum, additional, Seshadri, Chetan, additional, Kublin, James G., additional, and Murphy, Sean C., additional

Published
2023
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42. Risk of COVID-19 after natural infection or vaccination

Author

Rick, Anne-Marie, primary, Laurens, Matthew B., additional, Huang, Ying, additional, Yu, Chenchen, additional, Martin, Thomas C.S., additional, Rodriguez, Carina A., additional, Rostad, Christina A., additional, Maboa, Rebone M., additional, Baden, Lindsey R., additional, El Sahly, Hana M., additional, Grinsztejn, Beatriz, additional, Gray, Glenda E., additional, Gay, Cynthia L., additional, Gilbert, Peter B., additional, Janes, Holly E., additional, Kublin, James G., additional, Huang, Yunda, additional, Leav, Brett, additional, Hirsch, Ian, additional, Struyf, Frank, additional, Dunkle, Lisa M., additional, Neuzil, Kathleen M., additional, Corey, Lawrence, additional, Goepfert, Paul A., additional, Walsh, Stephen R., additional, Follmann, Dean, additional, Kotloff, Karen L., additional, Adams, Atoya, additional, Miller, Eric, additional, Rankin, Bruce G., additional, Shinn, Steven, additional, Nash, Marshall, additional, Green, Sinikka L., additional, Jacobsen, Colleen, additional, Krishnankutty, Jayasree, additional, Phungwayo, Sikhongi, additional, Glover, Richard M., additional, Slechta, Stacy, additional, Holdeman, Troy, additional, Hartvickson, Robyn, additional, Grant, Amber, additional, Poling, Terry L., additional, Klein, Terry D., additional, Klein, Thomas C., additional, Klein, Tracy R., additional, Smith, William B., additional, Gibson, Richard L., additional, Winbigler, Jennifer, additional, Parker, Elizabeth, additional, Wijewardane, Priyantha N., additional, Bravo, Eric, additional, Thessing, Jeffrey, additional, Maxwell, Michelle, additional, Horn, Amanda, additional, Healy, Catherine Mary, additional, Akamine, Christine, additional, Chu, Laurence, additional, Chouteau, R. Michelle, additional, Cotugno, Michael J., additional, Bauer, George H., additional, Hachigian, Greg, additional, Oshita, Masaru, additional, Cancilla, Michael, additional, Kiersey, Kristen, additional, Seger, William, additional, Antwi, Mohammed, additional, Green, Allison, additional, Kim, Anthony, additional, Desjardins, Michael, additional, Johnson, Jennifer A., additional, Sherman, Amy, additional, Borger, Judith, additional, Saleem, Nafisa, additional, Solis, Joel, additional, Medina, Martha Carmen, additional, Keating, Westly, additional, Garcia, Edgar, additional, Bueno, Cynthia, additional, Segall, Nathan, additional, Denham, Douglas S., additional, Weiss, Thomas, additional, Avworo, Ayoade, additional, Hedges, Parke, additional, Strout, Cynthia Becher, additional, Santiago, Rica, additional, Davis, Yvonne, additional, Howenstine, Patty, additional, Bondell, Alison, additional, Marks, Kristin, additional, Wang, Tina, additional, Wilkin, Timothy, additional, Vogler, Mary, additional, Johnston, Carrie, additional, Andrasik, Michele P., additional, Andriesen, Jessica G., additional, Broder, Gail, additional, Eaton, Niles, additional, Gelderblom, Huub G., additional, McClennen, Rachael, additional, Michael, Nelson, additional, Robb, Merlin, additional, Sopher, Carrie, additional, Miller, Vicki E., additional, Santiago, Fredric, additional, Gomez, Blanca, additional, Valika, Insiya, additional, Starr, Amy, additional, Cantos, Valeria D., additional, Kandiah, Sheetal, additional, Rio, Carlos del, additional, Rouphael, Nadine, additional, Edupuganti, Srilatha, additional, Anderson, Evan J., additional, Camacho-Gonzalez, Andres, additional, Kamidani, Satoshi, additional, Teherani, Meghan, additional, Diemert, David J., additional, Malkin, Elissa, additional, Siegel, Marc, additional, Roberts, Afsoon, additional, Simon, Gary, additional, Balani, Bindu, additional, Stephenson, Carolene, additional, Sperber, Steven, additional, Cicogna, Cristina, additional, Zervos, Marcus J., additional, Kilgore, Paul, additional, Ramesh, Mayur, additional, Herc, Erica, additional, Zenlea, Kate, additional, Burgher, Abram, additional, Milliken, Ann M., additional, Davis, Joseph D., additional, Levy, Brendan, additional, Kelman, Sandra, additional, Doust, Matthew W., additional, Sample, Denise, additional, Erickson, Sandra, additional, Christensen, Shane G., additional, Matich, Christopher, additional, Longe, James, additional, Witbeck, John, additional, Peterson, James T., additional, Clark, Alexander, additional, Kelty, Gerald, additional, Pena-Renteria, Issac, additional, Koren, Michael J., additional, Bartilucci, Darlene, additional, Patel, Alpa, additional, Tran, Carolyn, additional, Kennelly, Christina, additional, Brownlee, Robert, additional, Coleman, Jacob, additional, Webster, Hala, additional, Fierro, Carlos A., additional, Leistner, Natalia, additional, Thompson, Amy, additional, Gonzalez, Celia, additional, Jackson, Lisa A., additional, Suyehira, Janice, additional, Haber, Milton, additional, Regalado, Maria M., additional, Procasky, Veronica, additional, Lutat, Alisha, additional, Griffin, Carl P., additional, Hollister, Ripley R., additional, Brown, Jeremy, additional, Ronk, Melody, additional, Harper, Wayne L., additional, Cohen, Lisa, additional, Eckert, Lynn, additional, Hong, Matthew, additional, Rouhbakhsh, Rambod, additional, Danford, Elizabeth, additional, Johnson, John, additional, Calderone, Richard, additional, Khetan, Shishir K., additional, Olanrewaju, Oyebisi, additional, Zhai, Nan, additional, Nieves, Kimberly, additional, O'Brien, Allison, additional, Bradley, Paul S., additional, Lilienthal, Amanda, additional, Callis, Jim, additional, Brosz, Adam B., additional, Clement, Andrea, additional, West, Whitney, additional, Friesen, Luke, additional, Cramer, Paul, additional, Eder, Frank S., additional, Little, Ryan, additional, Engler, Victoria, additional, Rattenbury-Shaw, Heather, additional, Ensz, David J., additional, Oplinger, Allie, additional, Essink, Brandon J., additional, Meyer, Jay, additional, Raiser, Frederick, additional, Mueller, Kimberly, additional, Vrbicky, Keith W., additional, Harper, Charles, additional, Nutsch, Chelsie, additional, Lewis, Wendell, additional, Laflan, Cathy, additional, Whatley, Jordan L., additional, Harrell, Nicole, additional, Shannon, Amie, additional, Rowell, Crystal, additional, Dedon, Christopher, additional, Makhene, Mamodikoe, additional, Gottschlich, Gregory M., additional, Harden, Kate, additional, Gottschlich, Melissa, additional, Smith, Mary, additional, Powell, Richard, additional, Kimmel, Murray A., additional, Pinto, Simmy, additional, Vachris, Timothy P., additional, Hutchens, Mark, additional, Daniels, Stephen, additional, Wells, Margaret, additional, Van Der Leden, Mimi, additional, Jackson-Booth, Peta-Gay, additional, Baron, Mira, additional, Kane, Pamela, additional, Seversen, Shannen, additional, Kryvicky, Mara, additional, Lord, Julia, additional, Saleh, Jamshid, additional, Miles, Matthew, additional, Lupercio, Rafael, additional, McGettigan, John W., additional, Patton, Walter, additional, Brakema, Riemke, additional, Choquette, Karin, additional, McGettigan, Jonlyn, additional, Kirstein, Judith L., additional, Bernard, Marcia, additional, Manning, Mary Beth, additional, Rothenberg, Joan, additional, Briskin, Toby, additional, Roadman, Denise, additional, Tedder-Edwards, Sharita, additional, Schwartz, Howard I., additional, Mederos, Surisday, additional, Swaminathan, Shobha, additional, Nyaku, Amesika, additional, Varughese, Tilly, additional, DallaPiazza, Michelle, additional, Frey, Sharon E., additional, Graham, Irene, additional, Abate, Getahun, additional, Hoft, Daniel, additional, Allen, Leland N., additional, Edwards, Leslie A., additional, Davis, William S., additional, Mena, Jessica M., additional, Kutner, Mark E., additional, Caso, Jorge, additional, Moran, Maria Hernandez, additional, Carvajal, Marianela, additional, Mendez, Janet, additional, Wadsworth, Larkin T., additional, Adams, Michael R., additional, Iverson, Leslie, additional, Newberg, Joseph L., additional, Pearlman, Laura, additional, Nugent, Paul J., additional, Reynolds, Michele D., additional, Bashour, Jennifer, additional, Schmidt, Robert, additional, Sheth, Neil P., additional, Steil, Kenneth, additional, Toma, Ramy J., additional, Kirby, William, additional, Folmar, Pink, additional, Williams, Samantha, additional, Pickrell, Paul, additional, Mott, Stefanie, additional, Linebarger, Carol Ann, additional, Malbari, Hussain, additional, Pampe, David, additional, Fragoso, Veronica G., additional, Holloway, Lisa, additional, McKeown-Bragas, Cecilia, additional, Becker, Teresa, additional, Williams, Barton G., additional, Jones, William H., additional, Clark, Jesse L., additional, Shoptaw, Steven, additional, Vertucci, Michele, additional, Hernandez, Will, additional, Spector, Stephen A., additional, Moodley, Amaran, additional, Blumenthal, Jill, additional, Stangl, Lisa, additional, Deutsch, Karen, additional, Mullane, Kathleen M., additional, Pitrak, David, additional, Nuss, Cheryl, additional, Pi, Judy, additional, Fichtenbaum, Carl, additional, Powers-Fletcher, Margaret, additional, Saemann, Michelle, additional, Kohrs, Sharon, additional, Campbell, Thomas B., additional, Lauria, Andrew, additional, Mancilla, Jose C., additional, Dunlevy, Hillary, additional, Novak, Richard M., additional, Wendrow, Andrea, additional, Borgetti, Scott, additional, Ladner, Ben, additional, Chrisley, Lisa, additional, Young, Cheryl, additional, Doblecki-Lewis, Susanne, additional, Alcaide, Maria L., additional, Gonzales-Zamora, Jose, additional, Morris, Stephen, additional, Wohl, David, additional, Eron, Joseph, additional, Frank, Ian, additional, Dunbar, Debora, additional, Metzger, David, additional, Momplaisir, Florence, additional, Martin, Judith, additional, Hoberman, Alejandro, additional, Shope, Timothy, additional, Muniz, Gysella, additional, Rupp, Richard, additional, Stanford, Amber, additional, Berman, Megan, additional, Porterfield, Laura, additional, Lewis, Michael, additional, Ghadishah, Elham, additional, Yusin, Joseph, additional, Pham, Mai, additional, Creech, Clarence B., additional, Walker, Shannon, additional, Rolsma, Stephanie, additional, Samuels, Robert, additional, Thomsen, Isaac, additional, Kalams, Spyros A., additional, Wilson, Greg, additional, Lucksinger, Gregg H., additional, Parks, Kevin, additional, Israelsen, Ryan, additional, Ostovar, Jaleh, additional, Kelly, Kary, additional, Overcash, Jeffrey S., additional, Chu, Hanh, additional, Lee, Kia, additional, De La Cruz, Luis I., additional, Clemons, Steve, additional, Everette, Elizabeth, additional, Studdard, Suzanna, additional, Mohan, Gowdhami, additional, Tyson, Stefanie, additional, Peay, Alyssa-Kay, additional, Johnson, Danyel, additional, Feldman, Gregory J., additional, Suen, May-Yin, additional, Muenzner, Jacqueline, additional, Boscia, Joseph, additional, Siddiqui, Farhan, additional, Sanders, John, additional, Peacock, James, additional, Nasim, Julio, additional, Levin, Michael L., additional, Hussey, Julie, additional, Kulic, Marcy, additional, McKenzie, Mark M., additional, Deese, Teresa, additional, Osmundsen, Erica, additional, Sweet, Christy, additional, Ebuh, Valentine M., additional, Elnagar, Elwaleed, additional, Ebuh, Georgette, additional, Iwuala, Genevieve, additional, Han-Conrad, Laurie J., additional, Simmons, Todd, additional, Tarakjian, Denis, additional, Ackermann, Jeremy, additional, Adams, Mark S., additional, Alemán, José O., additional, Al-Ibrahim, Mohamed S., additional, Andes, David R., additional, Andrews, Jeb, additional, Arduino, Roberto C., additional, Bäcker, Martín, additional, Badillo, Diana, additional, Bainbridge, Emma, additional, Batteiger, Teresa A., additional, Bazan, Jose A., additional, Bedimo, Roger J., additional, Benitez, Jorge A., additional, Bennett, Annette R., additional, Bernstein, David I., additional, Bialobok, Kristin, additional, Boas, Rebecca, additional, Brady, Judith, additional, Brown, Cynthia, additional, Bunce, Catherine A., additional, Call, Robert S., additional, Campbell, Wesley, additional, Carmody, Ellie, additional, Carpenter, Christopher, additional, Carsons, Steven E., additional, Castellon, Marvin, additional, Castro, Mario, additional, Catan, Hannah, additional, Chang, Jennifer, additional, Chebib, Mouna G., additional, Chen, Corey M., additional, Cheng, Margaret, additional, Chow, Brian D.W., additional, Ciambruschini, Annie, additional, Connor, Joseph P., additional, Conway, James H., additional, Cooney, Maureen, additional, Curlin, Marcel, additional, De La Matta Rodriguez, Claudia, additional, Dedon, Jon F., additional, Degan, Emily, additional, Dickey, Michelle, additional, Dietz, Craig, additional, Dong, Jennifer L., additional, Dorcely, Brenda, additional, Dube, Michael P., additional, Dyer, Carmel B., additional, Eckhardt, Benjamin, additional, Ellerbeck, Edward, additional, Ewers, Evan C., additional, Falk, Amy, additional, Feijoo, Brittany, additional, Felsen, Uriel R., additional, Fiel, Tom, additional, Fitz-Patrick, David, additional, Fogarty, Charles M., additional, Ford, Stacy, additional, Forero, Lina M., additional, Formentini, Elizabeth, additional, Franco-Vitteri, Doris, additional, Frenck, Robert W., additional, Gharib, Elie, additional, Gharib, Suzanne, additional, Rucker, Rola G., additional, Goldenberg, James N., additional, González, Luis H., additional, Gray, Brett, additional, Greene, Rusty, additional, Grossberg, Robert M., additional, Guanira-Carranza, Juan V., additional, Guerreros Benavides, Alfredo Gilberto, additional, Guillory, Clint C., additional, Gunaratne, Shauna H., additional, Halpert, David, additional, Hamilton, Holli, additional, Hartman, William R., additional, Henderson, Sheryl L., additional, Herati, Ramin, additional, Guarin, Laura Hernandez, additional, Hilder, Robin, additional, Ho, Ken, additional, Hojat, Leila, additional, Hosek, Sybil G., additional, Jacobson, Jeffrey M., additional, Jay, Melanie, additional, Johnson, Diane H., additional, Jones, Kathleen S., additional, Jones-López, Edward C., additional, Justman, Jessica E., additional, Kahney, Scott, additional, Katz, Lois, additional, Katz, Melinda, additional, Kaul, Daniel, additional, Keefer, Michael C., additional, Kennedy, Ashley, additional, Knishinsky, Jennifer, additional, Kogelman, Laura, additional, Koletar, Susan L., additional, Kottkamp, Angelica, additional, Laguio-Vila, Maryrose, additional, Landovitz, Raphael J., additional, Lee, Jessica L., additional, Liu, Albert, additional, Llerena Zegarra, Eneyda Giuvanela, additional, Lok, Anna S., additional, Lovell, James, additional, Lubelchek, Ronald, additional, Lucaj, John, additional, Luckasen, Gary, additional, Luetkemeyer, Annie, additional, Lugogo, Njira Lucia, additional, Maenza, Janine, additional, Malvestutto, Carlos, additional, Mauri, Monica, additional, Maves, Ryan C., additional, Mayer, Kenneth H., additional, McCartney, Michael J., additional, McCort, Margaret E., additional, McElrath, M. Juliana, additional, McNairy, Meredith, additional, Merino, Fernando L., additional, Meyerowitz, Eric A., additional, Mitchell, Carol L., additional, Monaco, Cynthia L., additional, Muhammad, Sauda, additional, Muñoz-Gómez, Sigridh, additional, Munsiff, Sonal, additional, Nee, Paul, additional, Nollen, Nicole L., additional, Noor, Asif, additional, Lagos, Claudio Nuñez, additional, Okulicz, Jason F., additional, Oliver, Patrick A., additional, Ortega, Jessica, additional, Palmer, Steven, additional, Parameswaran, Lalitha, additional, Parikh, Purvi, additional, Parker, Susan, additional, Parungao, Reza, additional, Pavie, Juana R., additional, Madan, Rebecca P., additional, Peralta, Henry, additional, Petts, Jennifer, additional, Pierce, Kristen K., additional, Pretell Alva, E. Javier, additional, Purpura, Lawrence J., additional, Raabe, Vanessa, additional, Recuenco, Sergio E., additional, Richards, Tamara, additional, Riddler, Sharon A., additional, Rizzardi, Barbara, additional, Rokser, Rachel, additional, Rolle, Charlotte-Paige, additional, Rosen, Adam, additional, Rosen, Jeffrey, additional, Freese, Lena R., additional, Santolaya, María E., additional, Schipani, Linda M., additional, Schwartz, Adam, additional, Schwasinger-Schmidt, Tiffany, additional, Scott, Hyman, additional, Sha, Beverly E., additional, Shankaran, Shivanjali, additional, Shapiro, Adrienne E., additional, Sharp, Stephan C., additional, Shopsin, Bo, additional, Sims, Matthew D., additional, Skipper, Stephanie, additional, Smith, Derek M., additional, Smith, Michael J., additional, Sobhanie, M. Mahdee, additional, Sovic, Brit, additional, Sterling, Stephanie, additional, Striker, Robert, additional, Tafur Bances, Karla Beatriz, additional, Talaat, Kawsar R., additional, Tavel, Edward M., additional, Tieu, Hong V., additional, Tomaszewski, Christian, additional, Tomlinson, Ryan, additional, Torres, Juan P., additional, Torres, Julian A., additional, Treanor, John J., additional, Tukuru, Sade, additional, Ulrich, Robert J., additional, Utz, Gregory C., additional, Viar, Veronica, additional, Viau Colindres, Roberto A., additional, Walsh, Edward E., additional, Walsh, Mary C., additional, Walter, Emmanuel B., additional, Weidler, Jessica L., additional, Wu, Yi H., additional, Yang, Kinara S., additional, Yrivarren Giorza, Juan Luis, additional, Zemanek, Arthur L., additional, Zhang, Kevin, additional, Zingman, Barry S., additional, Gorman, Richard, additional, Paez, Carmen A., additional, Swann, Edith, additional, Takuva, Simbarashe G., additional, Greninger, Alex, additional, Roychoudhury, Pavitra, additional, Coombs, Robert W., additional, Jerome, Keith R., additional, Castellino, Flora, additional, Tong, Xiaomi, additional, Pavetto, Corrina, additional, Gipson, Teletha, additional, Tong, Tina, additional, Lee, Marina, additional, Zhou, James, additional, Fay, Michael, additional, McQuarrie, Kelly, additional, Nnadi, Chimeremma, additional, Sogbetun, Obiageli, additional, Ahmad, Nina, additional, De Proost, Ian, additional, Hoseyni, Cyrus, additional, Coplan, Paul, additional, Khan, Najat, additional, Ronco, Peter, additional, Furey, Dawn, additional, Meck, Jodi, additional, Vingerhoets, Johan, additional, Brandenburg, Boerries, additional, Custers, Jerome, additional, Hendriks, Jenny, additional, Juraszek, Jarek, additional, Marit de Groot, Anne, additional, Van Roey, Griet, additional, Heerwegh, Dirk, additional, Van Dromme, Ilse, additional, Méndez Galván, Jorge F., additional, Carrascal, Monica B., additional, Duran, Adriana Sordo, additional, Sanchez Guerrero, Laura Ruy, additional, Gómora Madrid, Martha Cecilia, additional, Barrat Hernández, Alejandro Quintín, additional, Guizar, Sharzhaad Molina, additional, González Estrada, Denisse Alejandra, additional, Martínez Pérez, Silvano Omar, additional, Zárate Hinojosa, Zindy Yazmín, additional, Ruiz-Palacios, Guillermo Miguel, additional, Cruz-Valdez, Aurelio, additional, Pacheco-Flores, Janeth, additional, Lara, Anyela, additional, Díaz-Miralrio, Secia, additional, Reyes Fentanes, María José, additional, Olmos Vega, Jocelyn Zuleica, additional, Méndez, Daniela Pineda, additional, Martínez, Karina Cano, additional, Alvarez León, Winniberg Stephany, additional, Ruiz Herrera, Vida Veronica, additional, Vázquez Saldaña, Eduardo Gabriel, additional, Camacho Choza, Laura Julia, additional, Vega Orozco, Karen Sofia, additional, Ortega Domínguez, Sandra Janeth, additional, Chacón, Jorge A., additional, Rivera, Juan J., additional, Cutz, Erika A., additional, Ortegón, Maricruz E., additional, Rivera, María I., additional, Browder, David, additional, Burch, Cortney, additional, Moye, Terri, additional, Bondy, Paul, additional, Browder, Lesley, additional, Manning, Rickey D., additional, Hurst, James W., additional, Sturgeon, Rodney E., additional, Wakefield, Paul H., additional, Kirby, John A., additional, Andersen, James, additional, Fearon, Szheckera, additional, Negron, Rosa, additional, Medina, Amy, additional, Hill, John M., additional, Rajasekhar, Vivek, additional, Williams, Hayes, additional, Cade, LaShondra, additional, Fouts, Rhodna, additional, Moya, Connie, additional, Anderson, Corey G., additional, Devine, Naomi, additional, Ramsey, James, additional, Perez, Ashley, additional, Tatelbaum, David, additional, Jacobs, Michael, additional, Menasche, Kathleen, additional, Mirkil, Vincent, additional, Winkle, Peter J., additional, Haggag, Amina Z., additional, Haynes, Michelle, additional, Villegas, Marysol, additional, Raja, Sabina, additional, Riesenberg, Robert, additional, Plavin, Stanford, additional, Lerman, Mark, additional, Woodside, Leana, additional, Johnson, Maria, additional, Healy, C. Mary, additional, Whitaker, Jennifer A., additional, Keitel, Wendy A., additional, Atmar, Robert L., additional, Horwith, Gary, additional, Mason, Robin, additional, Johnson, Lisa, additional, Dora, Tambra, additional, Murray, Deborah, additional, Ledbetter, Logan, additional, Ewing, Beverly, additional, Stephenson, Kathryn E., additional, Tan, Chen S., additional, Zash, Rebecca, additional, Ansel, Jessica L., additional, Jaegle, Kate, additional, Guiney, Caitlin J., additional, Henderson, Jeffrey A., additional, O'Leary, Marcia, additional, Enright, Kendra, additional, Kessler, Jill, additional, Ducheneaux, Pete, additional, Inniss, Asha, additional, Brandon, Donald M., additional, Davis, William B., additional, Lawler, Daniel T., additional, Oppong, Yaa D., additional, Starr, Ryan P., additional, Syndergaard, Scott N., additional, Shelly, Rozeli, additional, Majumder, Mashrur Islam, additional, Sugimoto, Danny, additional, Dugas, Jeffrey, additional, Rijos, Dolores, additional, Shelton, Sandra, additional, Hong, Stephan, additional, Schwartz, Howard, additional, Sanchez-Crespo, Nelia, additional, Schwartz, Jennifer, additional, Piedra, Terry, additional, Corral, Barbara, additional, Medina, Carmen, additional, Dever, Michael E., additional, Shah, Mitul, additional, Delgado, Michael, additional, Scott, Tameika, additional, Usdan, Lisa S., additional, McGill, Lora J., additional, Arnold, Valerie K., additional, Scatamacchia, Carolyn, additional, Anthony, Codi M., additional, Merchant, Rajan, additional, Yoon, Anelgine C., additional, Hill, Janet, additional, Ng-Price, Lucy, additional, Thompson-Seim, Teri, additional, Ackerman, Ronald, additional, Ackerman, Jamie, additional, Aristy, Florida, additional, Ketter, Nzeera, additional, Finley, Jon, additional, Stull, Mildred, additional, Murray, Monica, additional, Rizvi, Zainab, additional, Guerrero, Sonia, additional, Paliwal, Yogesh K., additional, Paliwal, Amit, additional, Gordon, Sarah, additional, Gordon, Bryan, additional, Montano-Pereira, Cynthia, additional, Galloway, Christopher, additional, Montros, Candice, additional, Aleman, Lily, additional, Shairi, Samira, additional, Van Ever, Wesley, additional, Freeman, George H., additional, Harmon, Esther L., additional, Cross, Marshall A., additional, Sales, Kacie, additional, Gular, Catherine Q., additional, Hepburn, Matthew, additional, Alderson, Nathan, additional, Harshell, Shana, additional, Mahgoub, Siham, additional, Maxwell, Celia, additional, Mellman, Thomas, additional, Thompson, Karl M., additional, Wortman, Glenn, additional, Kingsley, Jeff, additional, Pixler, April, additional, Curry, LaKondria, additional, Afework, Sarah, additional, Swanson, Austin, additional, Jacqmein, Jeffry, additional, Bowers, Maggie, additional, Robison, Dawn, additional, Mosteller, Victoria, additional, Garvey, Janet, additional, Easley, Mary, additional, Kurnat, Rebecca J., additional, Cornelison, Raymond, additional, Gower, Shanda, additional, Schnitz, William, additional, Heinzig-Cartwright, Destiny S., additional, Lewis, Derek, additional, Newton, Fred E., additional, Duhart, Aeiress, additional, Watkins, Breanz, additional, Ball, Brandy, additional, York, Jill, additional, Pickle, Shelby, additional, Musante, David B., additional, Silver, William P., additional, Belhorn, Linda R., additional, Viens, Nicholas A., additional, Dellaero, David, additional, Patel, Priti, additional, Lisec, Kendra, additional, Safirstein, Beth, additional, Zapata, Luz, additional, Gonzalez, Lazaro, additional, Quevedo, Evelyn, additional, Irani, Farah, additional, Grillo, Joseph, additional, Potts, Amy, additional, White, Julie, additional, Flume, Patrick, additional, Headden, Gary, additional, Taylor, Brandie, additional, Warden, Ashley, additional, Chamberlain, Amy, additional, Jeanfreau, Robert, additional, Jeanfreau, Susan, additional, Matherne, Paul G., additional, Caldwell, Amy, additional, Stahl, Jessica, additional, Vowell, Mandy, additional, Newhouse, Lauren, additional, Berthaud, Vladimir, additional, Takizala, Zudi-Mwak, additional, Beninati, Genevieve, additional, Snell, Kimberly, additional, Baker, Sherrie, additional, Walker, James, additional, Harrison, Tavane, additional, Miller, Meagan, additional, Otto, Janet, additional, Gray, Roni, additional, Wilson, Christine, additional, Nemecek, Tiffany, additional, Harrington, Hannah, additional, Eppenbach, Sally, additional, Bourgeois, Tana, additional, Folsom, Lyndsea, additional, Holt, Gregory, additional, Mirsaeidi, Mehdi, additional, Calderon, Rafael, additional, Lichtenberger, Paola, additional, Quintero, Jalima, additional, Martinez, Becky, additional, Immergluck, Lilly, additional, Johnson, Erica, additional, Chan, Austin, additional, Fas, Norberto, additional, Thomas-Seaton, LaTeshia, additional, Khizer, Saadia, additional, Staben, Jonathan, additional, Beresnev, Tatiana, additional, Jahromi, Maryam, additional, Marovich, Mary A., additional, Hutter, Julia, additional, Nason, Martha, additional, Ledgerwood, Julie, additional, Mascola, John, additional, Leibowitz, Mark, additional, Morales, Fernanda, additional, Delgado, Mike, additional, Sanchez, Rosario, additional, Vega, Norma, additional, Áñez, Germán, additional, Albert, Gary, additional, Coston, Erin, additional, Desai, Chinar, additional, Dunbar, Haoua, additional, Eickhoff, Mark, additional, Garcia, Jenina, additional, Kautz, Margaret, additional, Lee, Angela, additional, Lewis, Maggie, additional, McGarry, Alice, additional, McKnight, Irene, additional, Nelson, Joy, additional, Newingham, Patrick, additional, Price-Abbott, Patty, additional, Reed, Patty, additional, Vegas, Diana, additional, Wilkinson, Bethanie, additional, Smith, Katherine, additional, Woo, Wayne, additional, Cho, Iksung, additional, Glenn, Gregory M., additional, Dubovsky, Filip, additional, Fried, David L., additional, Haughey, Lynne A., additional, Stanton, Ariana C., additional, Rameaka, Lisa Stevens, additional, Rosenberg, David, additional, Tomatsu, Lee, additional, Gonzalez, Viviana, additional, Manalo, Millie, additional, Grunstra, Bernard, additional, Quinn, Donald, additional, Claybrook, Phillip, additional, Olds, Shelby, additional, Dye, Amy, additional, Cannon, Kevin D., additional, Chadwick, Mesha M., additional, Jordan, Bailey, additional, Hussey, Morgan, additional, Nevarez, Hannah, additional, Kelley, Colleen F., additional, Chung, Michael, additional, Moran, Caitlin, additional, Rebolledo, Paulina, additional, Bacher, Christina, additional, Barranco-Santana, Elizabeth, additional, Rodriguez, Jessica, additional, Mendoza, Rafael, additional, Ruperto, Karen, additional, Olivieri, Odette, additional, Ocaña, Enrique, additional, Wylie, Paul E., additional, Henderson, Renea, additional, Jenson, Natasa, additional, Yang, Fan, additional, Kelley, Amy, additional, Finkelstein, Kenneth, additional, Beckmann, David, additional, Hutchins, Tanya, additional, Escallon, Sebastian Garcia, additional, Johnson, Kristen, additional, Sligh, Teresa S., additional, Desai, Parul, additional, Huynh, Vincent, additional, Lopez, Carlos, additional, Mendoza, Erika, additional, Adelglass, Jeffrey, additional, Naifeh, Jerome G., additional, Kucera, Kristine J., additional, Chughtai, Waseem, additional, Jaffer, Shireen H., additional, Davis, Matthew G., additional, Foley, Jennifer, additional, Burgett, Michelle L., additional, Shlotzhauer, Tammi L., additional, Ingalsbe-Geno, Sarah M., additional, Duncanson, Daniel, additional, Kush, Kelly, additional, Nesbitt, Lori, additional, Sonnier, Cora, additional, McCarter, Jennifer, additional, Butcher, Michael B., additional, Fry, James, additional, Percy, Donna, additional, Freudemann, Karen, additional, Gebhardt, Bruce C., additional, Mangu, Padma N., additional, Schroeck, Debra B., additional, Davit, Rajesh K., additional, Hennekes, Gayle D., additional, Luft, Benjamin J., additional, Carr, Melissa, additional, Nachman, Sharon, additional, Pellecchia, Alison, additional, Smith, Candace, additional, Valenti, Bruno, additional, Bermudez, Maria I., additional, Peraita, Noris, additional, Delgado, Ernesto, additional, Arrazcaeta, Alicia, additional, Ramirez, Natalie, additional, Amador, Carmen, additional, Marafioti, Horacio, additional, Dang, Lyly, additional, Clement, Lauren, additional, Berry, Jennifer, additional, Allaw, Mohammed, additional, Geuss, Georgettea, additional, Miles, Chelsea, additional, Bittner, Zachary, additional, Werne, Melody, additional, Calinescu, Cornell, additional, Rodman, Shannon, additional, Rindt, Joshua, additional, Cooksey, Erin, additional, Harrison, Kristina, additional, Cooper, Deanna, additional, Horton, Manisha, additional, Philyaw, Amanda, additional, Jennings, William, additional, Alvarado, Hilario, additional, Baka, Michele, additional, Regalado, Malina, additional, Murray, Linda, additional, Naguib, Sherif, additional, Singletary, Justin, additional, Richmond, Sha-Wanda, additional, Omodele, Sarah, additional, Oppenheim, Emily, additional, Martinez, Reuben, additional, Andriulis, Victoria, additional, Singer, Leonard, additional, Blevins, Jeanne, additional, Thomas, Meagan, additional, Hull, Christine, additional, Pereira, Isabel, additional, Rivero, Gina, additional, Okonya, Tracy, additional, Downing, Frances, additional, Miller, Paulina, additional, Rhee, Margaret, additional, Stapleton, Katherine, additional, Klein, Jeffrey, additional, Hong, Rosamond, additional, Swan, Suzanne, additional, Wahlin, Tami, additional, Bennett, Elizabeth, additional, Salzl, Amy, additional, Phan, Sharine, additional, White, Jewel J., additional, Occhino, Amanda, additional, Paiano, Ruth, additional, McLaughlin, Morgan, additional, Swieboda, Elisa, additional, Garcia-Fragoso, Veronica, additional, Becerra, Maria G., additional, White, Toni, additional, Turley, Christine B., additional, McWilliams, Andrew, additional, Esinhart, Tiffany, additional, Montoya, Natasha, additional, Huskey, Shamika, additional, Paul, Leena, additional, Tashima, Karen, additional, Johnson, Jennie, additional, Neill, Marguerite, additional, Sanchez, Martha, additional, Rybak, Natasha, additional, Mileno, Maria, additional, Cohen, Stuart H., additional, Ruiz, Monica, additional, Boswell, Dean M., additional, Robison, Elizabeth E., additional, Reynolds, Trina L., additional, Neumeister, Sonja, additional, Zorrilla, Carmen D., additional, Rivera, Juana, additional, Ibarra, Jessica, additional, García, Iris, additional, Sierra, Dianca, additional, Ramon, Wanda, additional, Fiorillo, Suzanne, additional, Pitotti, Rebecca, additional, Anderson, Victoria R., additional, Mancilla, Jose Castillo, additional, Le, Nga, additional, Winokur, Patricia L., additional, Ince, Dilek, additional, Hegmann, Theresa, additional, Meier, Jeffrey, additional, Stapleton, Jack, additional, Stulken, Laura, additional, McArthur, Monica, additional, Berry, Andrea, additional, Tapia, Milagritos, additional, Hammershaimb, Elizabeth, additional, Robinson, Toni, additional, MacBryde, Rosa, additional, Kline, Susan, additional, Billings, Joanne L., additional, Cavert, Winston, additional, Forgosh, Les B., additional, Schacker, Timothy W., additional, Bold, Tyler D., additional, Dandachi, Dima, additional, Nelson, Taylor, additional, Bran, Andres, additional, Geiger, Grant, additional, Naqvi, S. Hasan, additional, Florescu, Diana F., additional, Starlin, Richard, additional, Kline, David, additional, Zimmer, Andrea, additional, Abbas, Anum, additional, Wilson, Natasha, additional, Eron, Joseph J., additional, Sciaudone, Michael, additional, Rosengren, A. Lina, additional, Kizer, John S., additional, Rutstein, Sarah E., additional, Bruce, Elizabeth, additional, Espinosa, Claudia, additional, Sanders, Lisa J., additional, Kim, Kami, additional, Casey, Denise, additional, Taylor, Barbara S., additional, Patterson, Thomas, additional, Pinilla, Ruth S., additional, Bullock, Delia, additional, Ponce, Philip, additional, Patterson, Jan, additional, McClelland, R. Scott, additional, Lane, Dakotah C., additional, Wald, Anna, additional, James, Frank, additional, Duke, Elizabeth, additional, Hauge, Kirsten, additional, Heimonen, Jessica, additional, Goecker, Erin A., additional, Fong, Youyi, additional, Kauffman, Carol, additional, Linder, Kathleen, additional, Nofz, Kimberly, additional, McConnell, Andrew, additional, Buynak, Robert J., additional, Webb, Angella, additional, Petty, Taryn, additional, Andree, Stephanie, additional, Sanchez, Erica, additional, Mackey, Nolan, additional, Baudelaire, Clarisse, additional, Dzigiel, Sarah, additional, Marquez, Adrienna, additional, Quillin, Kim, additional, King, Michelle, additional, Abad, Vanessa, additional, Knowles, Jennifer, additional, Waters, Michael, additional, Zepeda, Karla, additional, Coslet, Jordan, additional, Tovar, Dalia, additional, Shaw, Marian E., additional, Turner, Mark A., additional, Huffine, Cory J., additional, Huffine, Esther S., additional, Ake, Julie A., additional, Secord, Elizabeth, additional, McGrath, Eric, additional, Levy, Phillip, additional, Stewart, Brittany, additional, Cromer, Charnell, additional, Walters, Ayanna, additional, Ellsworth, Grant, additional, Greene, Caroline, additional, Galloway, Sarah, additional, Kapadia, Shashi, additional, DeHaan, Elliot, additional, Wilson, Clint, additional, Milligan, Jason, additional, Raley, Danielle, additional, Bocchini, Joseph, additional, McClenathan, Bruce, additional, Hussain, Mary, additional, Lomasney, Evelyn, additional, Hall, Evelyn, additional, Lamberth, Sherry, additional, Schmeck, Christy, additional, Leathers, Vickie, additional, Theodore, Deborah A., additional, Branche, Angela R., additional, Graciaa, Daniel S., additional, Hatlen, Timothy J., additional, Miller, Jacqueline, additional, Sadoff, Jerald, additional, Falsey, Ann R., additional, and Sobieszczyk, Magdalena E., additional

Published
2023
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43. Neutralizing antibody responses over time in demographically and clinically diverse individuals recovered from SARS-CoV-2 infection in the United States and Peru: A cohort study

Author

Karuna, Shelly, Li, Shuying Sue, Grant, Shannon, Walsh, Stephen R., Frank, Ian, Casapia, Martin, Trahey, Meg, Hyrien, Ollivier, Fisher, Leigh, Miner, Maurine D., Randhawa, April K., Polakowski, Laura, Kublin, James G., Corey, Lawrence, and Montefiori, David

Subjects
Demographic aspects, Patient outcomes, Health aspects, Antigen-antibody reactions -- Health aspects, Immune response -- Health aspects, COVID-19 -- Patient outcomes -- Demographic aspects
Abstract

Author(s): Shelly Karuna 1,*, Shuying Sue Li 1, Shannon Grant 1, Stephen R. Walsh 2, Ian Frank 3, Martin Casapia 4, Meg Trahey 1, Ollivier Hyrien 1, Leigh Fisher 1, [...], Background People infected with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) experience a wide range of clinical manifestations, from asymptomatic and mild illness to severe illness and death, influenced by age and a variety of comorbidities. Neutralizing antibodies (nAbs) are thought to be a primary immune defense against the virus. Large, diverse, well-characterized cohorts of convalescent individuals provide standardized values to benchmark nAb responses to past SARS-CoV-2 infection and define potentially protective levels of immunity. Methods and findings This analysis comprises an observational cohort of 329 HIV-seronegative adults in the United States (n = 167) and Peru (n = 162) convalescing from SARS-CoV-2 infection from May through October 2020. The mean age was 48 years (range 18 to 86), 54% of the cohort overall was Hispanic, and 34% identified as White. nAb titers were measured in serum by SARS-CoV-2.D614G Spike-pseudotyped virus infection of 293T/ACE2 cells. Multiple linear regression was applied to define associations between nAb titers and demographic variables, disease severity and time from infection or disease onset, and comorbidities within and across US and Peruvian cohorts over time. nAb titers peaked 28 to 42 days post-diagnosis and were higher in participants with a history of severe Coronavirus Disease 2019 (COVID-19) (p 55 years, male sex assigned at birth, and, in some cases, body mass index were also independently associated with higher nAb titers, whereas hypertension was independently associated with lower nAb titers. nAb titers did not differ by race, underlying pulmonary disease or smoking. Two months post-enrollment, nAb ID50 (ID80) titers declined 3.5 (2.8)-fold overall. Study limitations in this observational, convalescent cohort include survivorship bias and missing early viral loads and acute immune responses to correlate with the convalescent responses we observed. Conclusions In summary, in our cohort, nAb titers after SARS-CoV-2 infection peaked approximately 1 month post-diagnosis and varied by age, sex assigned at birth, disease severity, and underlying comorbidities. Our data show great heterogeneity in nAb responses among people with recent COVID-19, highlighting the challenges of interpreting natural history studies and gauging responses to vaccines and therapeutics among people with recent infection. Our observations illuminate potential correlations of demographic and clinical characteristics with nAb responses, a key element for protection from COVID-19, thus informing development and implementation of preventative and therapeutic strategies globally. Trial registration ClinicalTrials.gov NCT04403880.

Published
2021
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45. Selection of HIV vaccine candidates for concurrent testing in an efficacy trial

Author

Huang, Ying, DiazGranados, Carlos, Janes, Holly, Huang, Yunda, deCamp, Allan C, Metch, Barbara, Grant, Shannon, Sanchez, Brittany, Phogat, Sanjay, Koutsoukos, Marguerite, Kanesa-Thasan, Niranjan, Bourguignon, Patricia, Collard, Alix, Buchbinder, Susan, Tomaras, Georgia D, McElrath, Julie, Gray, Glenda, Kublin, James G, Corey, Lawrence, and Gilbert, Peter B

Published
2016
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46. HIV vaccines beyond COVID-19: merits of trust

Author

Kublin, James G.

Subjects
Control, Prevention, Analysis, Risk factors, Public opinion, AIDS vaccines -- Public opinion, HIV infections -- Risk factors -- Prevention, Epidemics -- Control -- Prevention -- United States, COVID-19 vaccines -- Public opinion, Health behavior -- Analysis, HIV infection -- Risk factors -- Prevention
Abstract

As contagion of sickness makes sickness, contagion of trust can make trust. In Distrust of Merits, Marianne Moore [1] The astonishing success of the SARS?CoV?2 vaccines reveals important aspects of [...]

Published
2021
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47. Daily Vaginal Swabs and Mobile Phone Sex Report for Assessing HIV Virion Exposure Prospectively Among a Cohort of Young Sexually Active Women in South Africa (HVTN 915)

Author

Lemos, Maria P., Lazarus, Erica, Isaacs, Abby, Dietrich, Janan, Morgan, Cecilia, Huang, Yunda, Grove, Doug, Andrasik, Michele, Laher, Fatima, Hural, John, Chung, Eva, Dragavon, Joan, Puren, Adrian, Gulati, Reena K., Coombs, Robert, McElrath, Margaret Juliana, Gray, Glenda, and Kublin, James G.

Published
2019
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49. Plasmodium 18S rRNA biomarker clearance after FDA-approved antimalarial treatment in controlled human malaria infection trials

Author

Chavtur, Chris, primary, Staubus, Weston J, additional, Ho, Mabel, additional, Hergott, Dianna E B, additional, Seilie, Annette M, additional, Healy, Sara, additional, Duffy, Patrick, additional, Jackson, Lisa, additional, Talley, Angela, additional, Kappe, Stefan H I, additional, Hoffman, Stephen L, additional, Richie, Thomas L, additional, Kublin, James G, additional, Chang, Ming, additional, and Murphy, Sean C, additional

Published
2023
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